
Herbs & Botanicals · Herbs · South African root extract for chest and cold symptoms, with low-certainty evidence and a liver warning
Pelargonium (Umckaloabo)
Pelargonium sidoides DC. (also Pelargonium reniforme (Andrews) Curtis) · also called Umckaloabo, EPs 7630 (a proprietary root extract), Stevens' Cure (historic name)
Pelargonium sidoides is a South African plant of the geranium family. Its root extract, best known as EPs 7630 or Umckaloabo, is taken for chest infections, coughs and colds. The best-studied uses are acute bronchitis and the common cold, but the Cochrane review rated the evidence low to very low, and most trials were short and linked to the manufacturer. The EU accepts it only as a traditional herbal medicine for cold symptoms, in adults and children from 3 years. Reports of liver injury exist, with unknown frequency, and it is not recommended in pregnancy or breastfeeding. Ask a doctor or pharmacist before using it if you take blood thinners.
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About Pelargonium (Umckaloabo)
Pelargonium sidoides is a South African root used as the extract EPs 7630 (Umckaloabo) for bronchitis, colds, cough and sinus infections. Trials mostly show lower symptom scores than placebo over about a week, but the Cochrane review rated the evidence low or very low, most trials are linked to the maker, and EU regulators accept only a traditional-use claim for colds. Liver injury has been reported with unknown frequency. It is not recommended in pregnancy, and its effect with blood thinners is unproven.
What it is
Pelargonium sidoides is a South African plant in the geranium family (Geraniaceae). The part used in medicine is the root. The best-known product is the extract EPs 7630, sold in Europe under names such as Umckaloabo. A related species, Pelargonium reniforme, is also allowed in the EU monograph.
Most research tests that one extract. The results do not carry over to garden geraniums, geranium oil or other root products.
What makes it distinctive
The root holds simple coumarins, many of them unusual, and tannins (proanthocyanidins). Lab studies suggest the extract helps the body's defences rather than killing germs directly, but this is from cells and animals.
EU assessors said many lab studies were poorly controlled and cannot explain the clinical effect.
Traditional and current uses
Healers in southern Africa used tuberous Pelargonium roots for many ailments, including complications of dysentery. A liquid root extract has been authorised in Germany since 1976 for acute bronchitis.
Today it is mainly taken for colds and chest infections. The EU accepts it only as a traditional herbal medicine for relieving cold symptoms.
What the research shows
Most trials are short (about a week) and test the EPs 7630 extract in acute bronchitis, colds and sinus infections. Most show lower symptom scores than placebo. The Cochrane review rated the evidence low or very low, noted suspected publication bias, and found liquid and tablet forms behaved differently.
The EU committee concluded that the placebo-controlled trials were not adequate to prove bronchitis efficacy, because they were run by the same investigators in the same region and did not pre-define a clinically relevant gain. Evidence for COPD, asthma, children's throat infections and hand, foot and mouth disease rests on one or two small studies.
No mind, mood or sleep uses have been studied. Nothing here shows the herb prevents colds or lung infections.
At a glance
Traditional uses history, not proof
- Southern African traditional medicine: tuberous Pelargonium roots used for many ailments, including complications of dysentery
- Early 1900s: a boiled root preparation for tuberculosis, as cited in the EU assessment report
- Germany since 1976: a liquid root extract authorised for acute bronchitis
- EU traditional use: symptomatic treatment of the common cold in adults and children from 3 years
Studied for research
- Acute bronchitis in adults, low certainty
- Acute bronchitis in children and teenagers, low certainty
- Cough and days off work or school, low certainty
- COPD flare-ups, very low certainty (one trial)
- Common cold, mixed certainty
- Acute sinus infection, low certainty
- Sore throat, other children's infections, hand, foot and mouth disease, asthma attacks during colds: very low or insufficient
Main compounds
- Simple coumarins, including scopoletin, fraxetin sulfates and umckalin
- Proanthocyanidins (tannins), at least 2.0 percent in the pharmacopoeia root
- Gallic acid and flavan-3-ols such as catechin and epicatechin
Common forms
- Liquid root extract (EPs 7630, ethanol-water)
- Dry root extracts in tablets
- Root powder and tinctures
- Combination products (not assessed here)
Research links: EU herbal medicine page: Pelargonii radix (European Medicines Agency) · EU assessment report on Pelargonium sidoides root (2024) · EU committee opinion (2024) with divergent positions · Cochrane review: Pelargonium sidoides extract for acute respiratory tract infections · Honchar 2026 systematic review (Phytomedicine) · Research Library · Genes & Biomarkers Library
The plant and its history
- Accepted scientific name
- Pelargonium sidoides DC.
- Naming authority
- DC. (de Candolle)
- Common names
- Umckaloabo (trade/traditional name used in Europe); Stevens' Cure (historic English product name (Brendler and van Wyk 2008)); Cape pelargonium (English (not verified in a source read)); pelargonio, geranio africano (Spanish (not verified))
- Botanical family
- Geraniaceae
- Classification
- Plantae > Tracheophyta > Magnoliopsida > Geraniales > Geraniaceae > Pelargonium > Pelargonium sidoides
- Native range
- Southern Africa (as stated in reviews); exact countries not verified here.
- Habitat
- Not verified in the sources read.
- What the plant looks like
- Roots: Underground organs (roots and tuber-like root parts) are the medicinal part; the European Pharmacopoeia defines Pelargonii radix as the dried, usually fragmented underground organs, with at least 2.0% tannins (as pyrogallol).; Stems: Not verified in the sources read.; Leaves: Not verified in the sources read; the aerial parts are rich in flavonoids and hydrolysable tannins (Kolodziej 2007).; Flowers: Not verified in the sources read.; Fruit: Not verified in the sources read.
- Cultivation
- Reviews describe wild harvest and note cultivation and biotechnology as conservation tools; details not verified here.
- Harvest and processing
- EPs 7630 is an extract of the root made with ethanol-water (EU report lists ethanol 11% for the liquid extract). Other preparations include powdered root, tincture and fluid extract.
- Look-alikes and adulterants
- Name: Pelargonium reniforme; Note: Related species also allowed by the EU monograph. The roots show different coumarin patterns that help tell them apart, and it contains a unique compound, reniformin (Kolodziej 2007; EU report).; Name: Pelargonium graveolens (rose geranium) and other garden geraniums; Note: A different species used for essential oil; not the same herbal medicine. Trials of Pelargonium sidoides do not apply to geranium oil.; Name: Other tuberous southern African Pelargonium species; Note: Several tuberous Pelargonium species are traditional medicines in southern Africa (Brendler and van Wyk 2008); products may not state which one is used.
- Sustainability and conservation
- A review reports localised overexploitation and illegal harvesting of wild P. sidoides in southern Africa as demand grew; the IUCN status was not looked up.
Traditional use and history history, not clinical proof
| Tradition or era | Documented use | Source |
|---|---|---|
| Southern African traditional medicine | Tuberous Pelargonium species, including P. sidoides, were used for a variety of ailments, including complications of dysentery, stomach and gut complaints and respiratory problems. | Brendler and van Wyk 2008 (J Ethnopharmacol); Moyo and Van Staden 2014. Details of which peoples used it were not verified here. |
| Early 1900s (tuberculosis) | A boiled powdered-root preparation for tuberculosis, citing a 1909 source (BMA). | EU assessment report (Bladt and Wagner 2007, citing BMA 1909). The details were read in the EU report only. |
| Commercial development in Europe | The remedy Stevens' Cure/Umckaloabo became a European medicine and then the standardised extract EPs 7630. | Brendler and van Wyk 2008. Dates and personal stories (for example the name of the English patient) are NOT verified. |
| Germany, 1976 | A liquid extract (1:8-10, ethanol 11%) was authorised for acute bronchitis, and has been on the market for more than 30 years according to the EU report. | EU assessment report (Table 3: MA 1976). |
| European Union, 2012-2024 | The EU herbal committee published a traditional-use monograph in 2012, revised it in 2018 and 2024, limited to symptomatic treatment of the common cold (liquid extract, two dry extracts); bronchitis efficacy was not accepted as well-established. | HMPC opinion 29 May 2024; EU assessment report (publication dates 2012 and 2018 as quoted in these documents). |
Traditional use shows how a plant was used. It does not show that a supplement works or is safe today.
What is inside, and how it may work
What the plant contains and how those compounds act in cells and animals. Laboratory and animal mechanisms are not proven effects in people.
Main compounds
| Compound | Family | Where it is concentrated | Activity studied | Level of evidence |
|---|---|---|---|---|
| Scopoletin (simple coumarin) PubChem 5280460 | coumarins | root | Tested in the lab for antibacterial activity; no clinical use as an isolated compound. 12 25 | Laboratory research |
| Umbelliferone (7-hydroxycoumarin) PubChem 5281426 | coumarins | root | A 7-hydroxycoumarin, the type the EU report says is found in the extract; these lack the structure of anticoagulant coumarins. Presence in P. sidoides root specifically was not confirmed. 12 | Pharmacological theory |
| Fraxetin (as fraxetin sulfate and fraxetin-7-O-glucoside) PubChem 5273569 | coumarins | root | Major constituents in an aqueous root extract by LC-MS (Schnitzler 2008, cited in the EU report). Coumarin sulfates appear confined to P. sidoides. 12 25 | Laboratory research |
| Umckalin (7-hydroxy-5,6-dimethoxycoumarin) | coumarins | root | With 6,8-dihydroxy-5,7-dimethoxycoumarin, the most active compounds against bacteria in a lab test (MIC 200-500 micrograms/ml); crude extract needed 5-7 mg/ml. 12 | Laboratory research |
| Gallic acid PubChem 370 | phenolic acids | root | One of the few phenolics found in relatively high yield; named in the EU report as a pharmacologically active constituent; its methyl ester is also present. 12 | Laboratory research |
| Epicatechin and catechin (flavan-3-ols) PubChem 72276 | flavonoids | root | Epicatechin was named as the bioactive marker compound of the P. sidoides part in a combination syrup (Park 2022); catechin is in the EU report list. CID given is epicatechin. 12 33 | Laboratory research |
| Proanthocyanidins (prodelphinidins; oligomeric and polymeric) | tannins | root Pharmacopoeia requires at least 2.0% tannins (as pyrogallol) in the dried root | Occur in high concentration, with catechin and gallocatechin units. The tannins may explain the mild gut upset, as the EU report suggests. 12 25 18 | Pharmacological theory |
| Coumarin (reference compound) PubChem 323 | coumarins | not specific | The parent coumarin; in rodents it is liver-toxic through a pathway that humans mostly lack. Used here only to explain EU assessors' reasoning, not as a P. sidoides ingredient. 12 | Authoritative guidance |
| Reniformin (diterpene) | diterpenes | root of P. reniforme | A unique diterpene ester found in the root of the related species, not in P. sidoides. 25 12 | Laboratory research |
Mechanisms, receptors and pathways
| Target or pathway | Gene or receptor | What was found | Level |
|---|---|---|---|
| Human monocyte activation | MAP kinases (p38); TNF-alpha, IL-6, IL-10 messengers | In cell experiments, EPs 7630 made human blood monocytes release TNF-alpha, IL-6 and IL-10 through MAP kinases; T-cells did not respond. A repeat stimulus then gave a more IL-6-dominant response. 48 | Laboratory research |
| Rhinovirus infection of airway lining cells | ICOS, ICOSL, calreticulin (C1qR) down; beta-defensin-1 and SOCS-1 up | In bronchial cells from people with asthma, COPD and healthy donors, EPs 7630 raised cell survival after rhinovirus and changed these proteins. 37 | Laboratory research |
| Phagocytosis and bacteria-host interaction | Not specified | Lab reviews report enhanced immune-cell activity and altered binding of group A streptococci to host cells. 10 31 | Laboratory research |
| Direct antibacterial effect | Not applicable | Crude extracts were only moderately active (MIC 5-7 mg/ml); isolated umckalin and a dimethoxycoumarin were stronger. A review says the demonstrated direct antibacterial activity cannot explain the clinical effect. 12 | Laboratory research |
| Broad antiviral and immune effects (review) | Multiple | A 2024 review (authors had a consultancy payment, likely from the maker) describes antibacterial, antiviral, immune and epithelial effects and argues these together explain clinical activity. The EU assessors judged that most lab studies lack controls and cannot explain the claimed effect. 9 12 | Laboratory research |
| Blood clotting | Not applicable | In rats, the extract did not change clotting times or warfarin's effect. 12 | Animal research |
Absorption, metabolism and elimination
- Absorption
- There are no human pharmacokinetic data for the extract itself (EU report). Constituents' blood levels in people have not been published for EPs 7630. In a different combination syrup with Coptis, food lowered epicatechin and berberine exposure.
- Distribution
- Not studied.
- Metabolism
- Not studied for the extract. For the parent compound coumarin, the EU report describes first-pass liver metabolism by CYP2A6 to 7-hydroxycoumarin in most people; this is background, not a result for Pelargonium.
- Elimination
- Not studied for the extract.
- Bioavailability
- Unknown for the extract. Food reduced epicatechin Cmax by about 29% and AUC by about 45% (not statistically significant) in 12 healthy men taking a Pelargonium-Coptis combination (UI026).
Isolated compounds versus whole extracts
All good-quality trials used the whole root extract EPs 7630 (an ethanol-water extract), so results cannot be moved to other Pelargonium products or to isolated compounds. Isolated coumarins and gallic acid showed activity in lab tests but have no clinical trials. The Cochrane review saw different results for liquid and tablet forms of the extract. A pooled analysis cannot be applied to P. reniforme, for which almost no trial data were found.
Nutritional composition
Pelargonium root extract is a herbal medicine, not a food or nutrient source. No vitamin or mineral content is claimed. The root contains tannins (at least 2.0% in the European Pharmacopoeia definition).
1 mixed findings6 low certainty4 very low certainty1 not enough evidence
What was looked at
The 12 benefits and uses checked for Pelargonium (Umckaloabo), each with how strong the evidence is. Tap one to open it.
- Acute bronchitis in adults: chest symptoms and recoveryLow certainty
- Acute bronchitis in children and teenagersLow certainty
- Cough: how much less and how quickly it stopsLow certainty
- Days off work and school with bronchitisLow certainty
- COPD: delaying flare-ups (add-on to usual treatment)Very low certainty
- Common cold in adults: symptom score and time to feel betterMixed findings
- Acute sinus infection (rhinosinusitis) in adultsLow certainty
- Sore throat (tonsillopharyngitis, not strep) in childrenVery low certainty
- Upper respiratory infections in children (general)Low certainty
- Hand, foot and mouth disease in young childrenVery low certainty
- Preventing asthma attacks during viral colds in childrenVery low certainty
- Respiratory infections in children with transient low antibody levelsNot enough evidence
Lab markers tracked in the studies
Bronchitis Severity Score (BSS)St George's Respiratory Questionnaire (SGRQ) total scoreDays unable to workTime to first COPD exacerbationCold Intensity Score (CIS)Sinusitis Severity Score (SSS)Tonsillopharyngitis Severity Score (TSS)Liver enzymes ALT and AST (safety monitoring)Clotting tests (Quick/PTT)
What is Pelargonium (Umckaloabo) good for?
The main proposed uses and how strong the human evidence is for each. "Low" is the best rating any use reached here, apart from a "mixed" rating for colds. "Very low" means one or two small studies. None of these is a proven treatment for you. Almost all evidence is for one specific root extract, EPs 7630. Ask a doctor or pharmacist if you take blood thinners or have liver disease.
Benefits, one by one
Each card is a research question, not a promise. Tap a goal to filter. Open a card to see the studies, doses and limits.
Acute bronchitis in adults: chest symptoms and recovery
Low certaintyIn adults with a short chest infection (acute bronchitis), a 7-day course of the EPs 7630 root extract reduced symptom scores more than placebo in several trials. The trials were short, mostly run by or for the manufacturer, and the Cochrane review rated the evidence low. Acute bronchitis usually clears by itself.
5 studiesEPs 7630 liquid, 30 drops three times daily for 7 days in the trials.…
Studies, doses and limits
What the trials found
Two placebo-controlled trials of EPs 7630 in adults with acute bronchitis (468 and 124 people, 30 drops three times daily for 7 days) both found a bigger drop in the Bronchitis Severity Score than placebo. The Cochrane review (2013) found three adult trials (746 people) but did not pool them because liquid and tablet forms behaved differently, and rated the quality low. An earlier meta-analysis (2008) of four placebo-controlled trials also found lower scores by day 7. The EU medicines committee (HMPC, 2024) did not accept bronchitis efficacy as proven for this extract, because the trials were run by the same investigators in Ukraine and Russia, and did not pre-define a clinically relevant difference.
Results
Matthys 2003: Bronchitis Severity Score fell 5.9 points with EPs 7630 vs 3.2 with placebo (95% CI for difference -3.359 to -2.060). Chuchalin 2005: fell 7.2 vs 4.9 (95% CI 1.21 to 3.56). Inability to work after treatment: 16% vs 43% in the larger trial.
Effect sizes as reported
Score difference about 2.3 to 2.7 points on the Bronchitis Severity Score; the EU committee says at least 4 points is needed to call it a strong, clinically relevant effect in adults.
Why this rating
Cochrane rated the evidence low; the trials are short, mainly from one sponsor and region, publication bias was suspected, and EU regulators did not accept it as well-established.
Form and dose studied
EPs 7630 liquid, 30 drops three times daily for 7 days in the trials. Ask a doctor or pharmacist about amounts and which product.
Who was studied
Adults with acute bronchitis for under 48 hours who did not need antibiotics.
Limits
Self-rated symptom scores; short follow-up; manufacturer-linked; not shown to prevent complications.
Why researchers looked
Acute bronchitis is mostly caused by viruses, antibiotics often do not help, and people look for other ways to ease coughing and chest symptoms.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Acute bronchitis in children and teenagers
Low certaintyIn children and teenagers with acute bronchitis, three placebo-controlled trials of EPs 7630 found bigger symptom improvement than placebo within a week. Evidence is rated low, and EU regulators have raised concerns about how the trials mixed ages and about use in young children.
9 studiesLiquid EPs 7630 for 7 days in the trials; children's amounts depend o…
Studies, doses and limits
What the trials found
Three double-blind trials (200, 220 and 400 children and teenagers aged 1-18 or 6-18) found a bigger fall in the Bronchitis Severity Score than placebo after 7 days. The Cochrane review pooled 819 children in three trials but did not combine results and rated quality low. A pooled analysis of 6 trials in children (Anheyer 2018) reported a responder rate ratio of 2.56, which the authors called moderate evidence. A 2023 open-label safety trial in 591 children aged 1-5 had no placebo group, so it cannot show benefit. EU assessors said the trials mixed age groups and some posologies did not match the product information.
Results
Kamin 2010: Bronchitis Severity Score improved 3.4 vs 1.2 points (EPs 7630 vs placebo). Kamin 2012: 4.4 vs 2.9 points. Dose-finding trial in 400 patients aged 6-18: the 60 mg and 90 mg daily groups beat placebo.
Effect sizes as reported
Differences of about 1.5 to 2.2 points on the score. Anheyer meta-analysis: responder RR 2.56 (95% CI 1.54-4.26).
Why this rating
Reviewer GRADE was low (Cochrane); one meta-analysis said moderate; trials were manufacturer-linked and EU assessors criticised design. Open-label safety studies add no efficacy evidence.
Form and dose studied
Liquid EPs 7630 for 7 days in the trials; children's amounts depend on age. Ask a doctor or pharmacist.
Who was studied
Children and teenagers aged 1-18 with bronchitis outside the strict need for antibiotics.
Limits
Mixed age groups analysed together; self- or parent-rated scores; manufacturer-linked. EU members (Ireland, Italy, Netherlands) disagreed with the monograph for young children.
Why researchers looked
Cough and chest infections are very common in children, and parents look for options that avoid antibiotics.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab. Italy and the Netherlands said evidence on liver safety is not enough for children under 6.
Cough: how much less and how quickly it stops
Low certaintyPooling 11 placebo-controlled trials, more people on EPs 7630 had much less cough or no cough by day 5 to 7. This is the clearest single symptom signal, but the pooled trials are mostly manufacturer-linked and the pooling was done by the manufacturer's team.
2 studiesEPs 7630 liquid or tablets for 5-7 days in the trials. Ask a doctor o…
Studies, doses and limits
What the trials found
A 2022 meta-analysis of 11 placebo-controlled trials (2,195 people) in bronchitis and the common cold found cough responses favouring EPs 7630. A 2015 review of herbal cough remedies (34 trials, 11 on Pelargonium) reported moderate evidence for Pelargonium (RR 4.60). Both used trials of the same extract.
Results
Adults with bronchitis, day 7: 88.7% vs 47.6% had at least half less cough (RR 2.13) and 26.0% vs 6.3% had no cough (RR 5.00). Children/teens with bronchitis: 79.6% vs 41% (RR 1.86); no cough 18.0% vs 5.5%. Common cold, day 5: 56.8% vs 38.8% (RR 1.40).
Effect sizes as reported
RR 2.13 (1.37-3.31) and 5.00 (3.10-8.07) in adults; RR 1.86 (1.34-2.95) and 2.91 (1.26-6.72) in children. Wagner 2015: RR 4.60 (2.89-7.31).
Why this rating
No GRADE or risk-of-bias rating in the abstracts; authors have manufacturer links (Kardos 2022 affiliation) and trials are the same ones judged low-quality by Cochrane.
Form and dose studied
EPs 7630 liquid or tablets for 5-7 days in the trials. Ask a doctor or pharmacist about amounts.
Who was studied
Adults and children with bronchitis or the common cold.
Limits
Cough scores come from patient diaries and clinician rating; self-limiting illness; manufacturer-linked pooling.
Why researchers looked
Cough is the most disturbing symptom of bronchitis and colds.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Days off work and school with bronchitis
Low certaintyMeta-analyses of manufacturer-linked trials found fewer sick days in adults and more children able to return to school with EPs 7630 than with placebo. These are practical outcomes but depend on self-report and on a short, self-limiting illness.
2 studiesEPs 7630 for 6-7 days in the trials.
Studies, doses and limits
What the trials found
Four placebo-controlled trials in 1,011 adults found about 1.7 fewer sick days. In 523 children aged 6-10 (bronchitis and tonsillopharyngitis), fewer were unable to attend school at treatment end and slightly less paracetamol was used.
Results
Adults: still unable to work after 7 days in 14-19% vs 41-55% (RR 0.35). About 1.73 fewer sick days (95% CI 1.17-2.29). Children aged 6-10: unable to attend school 30.2% vs 74.4% (RR 0.43); paracetamol about 244 mg less.
Effect sizes as reported
Adults RR 0.35 (0.26-0.45); children RR 0.43 (0.29-0.65).
Why this rating
Pools of manufacturer-linked trials; sick leave is partly self-reported.
Form and dose studied
EPs 7630 for 6-7 days in the trials.
Who was studied
Adults with acute bronchitis; children aged 6-10.
Limits
Short illness resolves anyway; no independent replication of the pooled outcome.
Why researchers looked
Lost working days are a big cost of bronchitis.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
COPD: delaying flare-ups (add-on to usual treatment)
Very low certaintyOne 24-week trial in 200 adults with moderate to severe COPD found a longer time to the first flare-up with EPs 7630 added to usual treatment. It has not been repeated by independent groups, so confidence is very low.
2 studiesEPs 7630 liquid, 30 drops three times daily for 24 weeks as add-on. A…
Studies, doses and limits
What the trials found
In a double-blind trial, patients with COPD stage II/III took EPs 7630 (30 drops three times daily, n=99) or placebo (n=101) for 24 weeks on top of standard treatment. Time to first flare-up was longer. A secondary analysis found better quality-of-life scores.
Results
Median time to first exacerbation 57 vs 43 days (p=0.005, one-sided test). Fewer exacerbations and fewer patients on antibiotics. Gut side effects (mild) were more common on EPs 7630. SGRQ quality-of-life gap exceeded the 4-point minimal important difference.
Effect sizes as reported
14 days longer median time to first flare-up; one-sided p-value.
Why this rating
One trial, one-sided test, not independently repeated; EU assessors treat this indication outside the monograph.
Form and dose studied
EPs 7630 liquid, 30 drops three times daily for 24 weeks as add-on. Ask a doctor; never replace COPD medicines.
Who was studied
Adults with COPD stage II/III.
Limits
Single trial; 24 weeks; no hard outcomes like hospital stays reported in the abstract.
Why researchers looked
Flare-ups of COPD are often triggered by infections and cause hospital stays.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab. The longer 24-week use is more than the 7-10 days used for infections; liver safety over months is not well studied.
Common cold in adults: symptom score and time to feel better
Mixed findingsFive trials of EPs 7630 in adults with a common cold found bigger symptom improvement than placebo at day 5 and day 10. The Cochrane review rated this evidence very low, while a later network analysis rated it moderate, so reviewers disagree. Colds go away by themselves.
6 studiesEPs 7630 liquid 30 drops three times daily, or tablets, for up to 10 …
Studies, doses and limits
What the trials found
A meta-analysis of 5 double-blind trials (833 adults, 10 days of treatment) found a lower Cold Intensity Score with EPs 7630 at days 5 and 10, fewer missed work days and less paracetamol. The two largest single trials had 103 and 105 patients. The Cochrane review had only one cold trial and rated the evidence very low (benefit at 10 days, not 5). A network meta-analysis (Hoang 2023, 47 trials, GRADE) rated Pelargonium sidoides best for common cold symptoms with moderate certainty. The EU committee accepted only the traditional-use claim for symptomatic treatment of the common cold, and said efficacy in this infection had not been proven adequately.
Results
Lizogub 2007 (n=103): clinically cured at day 10 78.8% vs 31.4%. Riley 2019 (n=105, tablets): cured at day 10 45% vs 12%. Meta-analysis: Cold Intensity Score difference -2.30 at day 5 and -1.16 at day 10; complete remission RR 2.52 (day 5) and 2.13 (day 10).
Effect sizes as reported
MD -2.30 (95% CI -4.12 to -0.49) at day 5; MD -1.16 (-2.22 to -0.10) at day 10.
Why this rating
Reviewers disagree: Cochrane very low (one trial); network meta-analysis moderate; EU committee accepted traditional use only. Trials are small and manufacturer-linked.
Form and dose studied
EPs 7630 liquid 30 drops three times daily, or tablets, for up to 10 days in the trials. Ask a doctor or pharmacist about amounts.
Who was studied
Adults with cold symptoms for 24-48 hours.
Limits
Small trials; patient-scored; the cold is self-limiting; manufacturer-linked.
Why researchers looked
People look for something to shorten the common cold and ease symptoms without antibiotics, which do not work on cold viruses.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Acute sinus infection (rhinosinusitis) in adults
Low certaintyOne placebo-controlled trial in 103 adults with an acute sinus infection found a larger symptom drop with EPs 7630 than with placebo. A small open trial found it beat amoxicillin on symptom scores. Evidence is thin and rated low or very low.
4 studiesEPs 7630 60 drops three times daily for up to 22 days in the sinusiti…
Studies, doses and limits
What the trials found
Bachert 2009 (n=103) was stopped early at an interim look after showing a bigger fall in the Sinusitis Severity Score. The Cochrane review rated this very low quality. Perić 2020 randomly gave 50 adults EPs 7630 tablets or amoxicillin for 10 days, open-label, and found better symptom and endoscopy scores with EPs 7630 for most items but no difference for runny nose or postnasal drip. A network meta-analysis found Pelargonium among the best options for acute post-viral rhinosinusitis symptoms (moderate certainty by the authors).
Results
Bachert 2009: SSS fell 5.5 vs 2.5 points (difference 3.0, 95% CI 2.0 to 3.9). Perić 2020: improvement in total symptom score greater with EPs 7630 than amoxicillin (p<0.001); no adverse events reported.
Effect sizes as reported
SSS difference 3.0 points (2.0-3.9). Cochrane: complete resolution at day 21 RR 0.43 (0.30-0.62).
Why this rating
One stopped-early placebo trial plus one small open-label comparison; Cochrane very low; network meta-analysis moderate for post-viral cases.
Form and dose studied
EPs 7630 60 drops three times daily for up to 22 days in the sinusitis trial (a higher dose than for bronchitis); tablets 20 mg three times daily for 10 days in the open trial. Ask a doctor or pharmacist.
Who was studied
Adults with acute rhinosinusitis, some presumed bacterial.
Limits
Trial stopped early can exaggerate benefit; open-label small comparison with an antibiotic that may not have been needed; no long-term follow-up.
Why researchers looked
Sinus infections are common; many are viral and antibiotics are often not needed.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab. Do not use it in place of antibiotics if a doctor says they are needed.
Sore throat (tonsillopharyngitis, not strep) in children
Very low certaintyOne placebo-controlled trial in 143 children aged 6-10 found sore-throat scores dropped much more with EPs 7630 than placebo. A 2023 systematic review of remedies for children's tonsillitis found the study quality insufficient to draw reliable conclusions.
3 studiesEPs 7630 20 drops three times daily for 6 days in the trial.
Studies, doses and limits
What the trials found
Bereznoy 2003 included children aged 6-10 with a negative rapid strep test and compared EPs 7630 with placebo for 6 days. Büttner 2023 found only five studies of complementary approaches for tonsillitis in children and judged them too weak for a reliable conclusion. Older uncontrolled studies in children under 6 were summarised by Kamin 2018.
Results
TSS fell 7.1 vs 2.5 points by day 4; authors say illness was shortened by at least 2 days.
Effect sizes as reported
Adjusted difference 95% interval 2.7 to 4.9 points.
Why this rating
One trial from one group; systematic review calls overall quality insufficient.
Form and dose studied
EPs 7630 20 drops three times daily for 6 days in the trial.
Who was studied
Children aged 6-10 with non-strep tonsillopharyngitis.
Limits
Only one trial; unusual adverse-event counts in the abstract; sponsor-linked product. Strep throat needs a doctor.
Why researchers looked
Most children's sore throats are viral and do not need antibiotics.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Upper respiratory infections in children (general)
Low certaintyA small single-blind trial in 164 children found a very small extra drop in symptom score. Pooled results from older trials in children favoured the extract, but EU regulators set aside the newer trial because it used a score that was not validated.
4 studiesLiquid root extract for 7 days in the trial.
Studies, doses and limits
What the trials found
Gökçe 2021 (n=164, aged 1-18, single-blind) found total symptom scores fell 0.85 vs 0.62 points. The EU assessors did not use it because the score was not validated. Anheyer 2018 pooled 6 Pelargonium trials in children and reported a higher responder rate. Kamin 2018 reviewed 7 studies in children under 6; only two were controlled.
Results
Gökçe: symptom score fell 0.85 vs 0.62 points (p=0.018); cough frequency better by day 3. Anheyer: responder RR 2.56.
Effect sizes as reported
RR 2.56 (1.54-4.26) for responders; adverse events RR 1.06 (0.42-2.66).
Why this rating
Very small effect in the newer trial; older pooled analysis is moderate by its authors but the trials are manufacturer-linked.
Form and dose studied
Liquid root extract for 7 days in the trial.
Who was studied
Children with colds and throat/nose infections.
Limits
Single-blind, small effect, non-validated score; ages mixed.
Why researchers looked
Children catch many colds and throat and nose infections each year.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab. Regulators disagree about safe use in children under 6 or 12.
Hand, foot and mouth disease in young children
Very low certaintyOne open-label Turkish study in 208 children found a shorter illness (about 2.5 days) with EPs 7630 than in the comparison group, but with no placebo and a risk of bias from knowing the treatment.
1 studiesEPs 7630; dose not stated in the abstract.
Studies, doses and limits
What the trials found
Sütçü 2024 randomised 208 children within 48 hours of onset to EPs 7630 or no EPs 7630 in an open-label design. The EPs 7630 group recovered faster and was hospitalised less. Only unpleasant taste was reported.
Results
Mean illness 6.07 days vs 8.58 days (p<0.001); hospitalisation lower (p=0.019).
Effect sizes as reported
2.5 days shorter.
Why this rating
Open-label, no placebo, single study, outcomes depend on parental report.
Form and dose studied
EPs 7630; dose not stated in the abstract.
Who was studied
Children median age 27 months.
Limits
No blinding, no placebo.
Why researchers looked
There is no specific treatment for this viral illness.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Preventing asthma attacks during viral colds in children
Very low certaintyOne small trial in 61 asthmatic children with a cold found fewer asthma attacks after 5 days of EPs 7630 than with no treatment. The control group had no placebo and details are thin, so this is a hint, not proof.
2 studiesEPs 7630 daily for 5 days.
Studies, doses and limits
What the trials found
Tahan 2013 randomised asthmatic children with a viral upper respiratory infection to EPs 7630 for 5 days (n=30) or no treatment (n=31). The treated group had fewer asthma attacks and less cough and congestion; there was no difference in fever or muscle aches. Lab work (Roth 2019) found EPs 7630 improved survival of bronchial cells infected with rhinovirus, but this is cell-dish evidence.
Results
Fewer asthma attacks with EPs 7630 (p<0.05); no attack counts given in the abstract.
Why this rating
One small unblinded trial; no counts in the abstract.
Form and dose studied
EPs 7630 daily for 5 days.
Who was studied
Children with asthma and a cold.
Limits
Unblinded; small; not repeated.
Why researchers looked
Colds trigger asthma attacks, and there is no proven way to prevent them.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab. Asthma should be managed by a doctor; do not replace prescribed asthma medicines.
Respiratory infections in children with transient low antibody levels
Not enough evidenceA tiny pilot (28 children) found no significant benefit for congestion or cough, apart from better appetite. Evidence is insufficient.
1 studiesPelargonium sidoides extract for 1 week; dose not in the abstract.
Studies, doses and limits
What the trials found
Patiroglu 2012 gave 14 children Pelargonium sidoides extract and 14 children placebo for a week during an upper respiratory infection and also checked blood counts, clotting and liver tests before and after. Benefit for congestion and cough was not significant.
Results
Appetite higher with the extract; congestion and cough improvement not significant.
Why this rating
Very small pilot with no significant benefit on main symptoms.
Form and dose studied
Pelargonium sidoides extract for 1 week; dose not in the abstract.
Who was studied
Children with transient hypogammaglobulinemia of infancy.
Limits
14 vs 14 children; underpowered.
Why researchers looked
Children with transient hypogammaglobulinemia of infancy (low antibodies) get frequent infections.
Traditional use
Zulu, Xhosa and Sotho healers in southern Africa used Pelargonium roots, including for cough, chest complaints and diarrhoea (EU assessment and review by Brendler and van Wyk). A liquid root extract has been authorised in Germany since 1976 for acute bronchitis, and the extract EPs 7630 was developed from this root.
Proposed mechanism Preliminary mechanism
Lab studies suggest the extract works by helping immune cells and the airway lining defend against germs, rather than by killing germs directly. Effects were seen in cell and animal studies; the exact effect in people is not shown.
A proposed mechanism does not show that the effect happens in people.
Mild stomach upset is the most common side effect. Rare allergic reactions occur. Reports of liver injury exist; regulators advise stopping the product and seeing a doctor if liver signs appear. See Safety tab.
Connections to the rest of health
How Pelargonium (Umckaloabo) connects to the rest of our health knowledge graph. Every link says what kind of connection it is. A safety link (for example to the liver) is a warning, not a benefit. A study that merely mentions a topic never creates a benefit link.
Explore every connection: goals, body systems, organs, symptoms, genes
A. Wellness goals
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Immune Support | Demonstrated clinical effect | Low certainty | Acute bronchitis in adults: chest symptoms and recovery: In adults with a short chest infection (acute bronchitis), a 7-day course of the EPs 7630 root extract reduced symptom scores more than placebo in several trials. The trials were short, mostly run by or for the manufacturer, and the Cochrane review rated the evidence low. Acute bronchitis usually clears by itself. Acute bronchitis in children and teenagers: In children and teenagers with acute bronchitis, three placebo-controlled trials of EPs 7630 found bigger symptom improvement than placebo within a week. Evidence is rated low, and EU regulators have raised concerns about how the trials mixed ages and about use in young children. | 27 8 46 1 12 19 21 20 3 22 23 13 24 47 30 39 26 36 38 17 |
| Immune Support | Potential benefit | Very low certainty | COPD: delaying flare-ups (add-on to usual treatment): One 24-week trial in 200 adults with moderate to severe COPD found a longer time to the first flare-up with EPs 7630 added to usual treatment. It has not been repeated by independent groups, so confidence is very low. Acute sinus infection (rhinosinusitis) in adults: One placebo-controlled trial in 103 adults with an acute sinus infection found a larger symptom drop with EPs 7630 than with placebo. A small open trial found it beat amoxicillin on symptom scores. Evidence is thin and rated low or very low. | 28 29 4 35 46 17 5 7 22 16 3 13 41 42 37 34 |
B. Body systems
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Hepatic system | Contraindication | Not enough evidence | No safety studies in liver disease; avoid unless a doctor agrees. Preparation or compound: Pelargonium sidoides root extract |
12 13 |
| Immune system | Adverse effect or risk | Low certainty | Allergic reactions including rare anaphylaxis (34 reports to WHO centre). Preparation or compound: Pelargonium sidoides root extract |
12 |
| Reproductive system | Contraindication | Not enough evidence | Pregnancy and breastfeeding: safety not established; not recommended. Preparation or compound: Pelargonium sidoides root extract |
12 |
| Respiratory system | Demonstrated clinical effect | Low certainty | Lower symptom scores than placebo in short bronchitis, cold and sinus trials; evidence low to very low and mostly manufacturer-linked. Preparation or compound: Pelargonium sidoides root extract (EPs 7630) |
46 24 27 8 12 |
| Immune system | Preliminary mechanism | Very low certainty | Cell studies show activation of immune cells and effects on rhinovirus infection of airway cells. Not shown in people. Preparation or compound: EPs 7630 |
48 37 |
| Respiratory System | Biological association | Low certainty | Studied for: Acute bronchitis in adults: chest symptoms and recovery Studied for: Acute bronchitis in children and teenagers | 27 8 46 1 12 19 21 20 3 22 23 13 24 47 30 39 28 29 26 36 38 17 4 35 5 7 16 42 37 |
| Immune System | Biological association | Low certainty | Studied for: Acute bronchitis in adults: chest symptoms and recovery Studied for: Acute bronchitis in children and teenagers | 27 8 46 1 12 19 21 20 3 22 23 13 26 36 38 17 4 35 5 7 16 41 42 37 34 |
C. Body parts and organs
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Liver | Adverse effect or risk | Low certainty | Spontaneous reports of hepatitis and liver injury; regulators judged an association at least possible, re-assessments found no probable cases; frequency unknown. A safety relationship, not a benefit. Hepatitis and liver injury reported with unknown frequency; EU warning to stop and see a doctor. Preparation or compound: Pelargonium sidoides root extract (EPs 7630 and other root products) |
12 43 44 11 2 |
| Blood vessels | Drug or supplement interaction | Not enough evidence | Theoretical effect with warfarin; rat and short human trial data reassuring; nose and gum bleeding listed. Theoretical bleeding or warfarin question; animal and short human data reassuring; nose and gum bleeding listed. Preparation or compound: Coumarins in Pelargonium roots; EPs 7630 |
12 27 8 |
I. Biomarkers
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Bronchitis Severity Score (BSS) | Biological association | Low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 27 8 19 21 12 |
| St George's Respiratory Questionnaire (SGRQ) total score | Biological association | Very low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 29 |
| Days unable to work | Biological association | Low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 30 27 |
| Time to first COPD exacerbation | Biological association | Very low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 28 |
| Cold Intensity Score (CIS) | Biological association | Mixed findings | Measured in trials: lowered. A lab change is not the same as a health benefit. | 26 36 38 |
| Sinusitis Severity Score (SSS) | Biological association | Low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 4 |
| Tonsillopharyngitis Severity Score (TSS) | Biological association | Very low certainty | Measured in trials: lowered. A lab change is not the same as a health benefit. | 5 |
| Liver enzymes ALT and AST (safety monitoring) | Biological association | Low certainty | Measured in trials: no-change. A lab change is not the same as a health benefit. | 12 23 34 |
| Clotting tests (Quick/PTT) | Biological association | Low certainty | Measured in trials: no-change. A lab change is not the same as a health benefit. | 12 |
J. Genes, receptors and enzymes
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| MAPK14 (p38 MAP kinase) | Preliminary mechanism | In vitro | p38 inhibition reduced monocyte TNF-alpha release in the lab after EPs 7630 exposure. | 48 |
| DEFB1 (beta-defensin-1) | Preliminary mechanism | In vitro | Higher protein levels in bronchial cells exposed to EPs 7630. | 37 |
| SOCS1 | Preliminary mechanism | In vitro | Higher protein levels in bronchial cells exposed to EPs 7630. | 37 |
| ICOS and ICOSLG | Preliminary mechanism | In vitro | Lower expression in infected bronchial cells treated with EPs 7630. | 37 |
| CYP2A6 | Preliminary mechanism | Authoritative guidance | Background only: handles the parent compound coumarin; people with low activity use another pathway. Not shown for the Pelargonium extract. | 12 |
K. Biological pathways
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Cytokine release (TNF-alpha, IL-6, IL-10) | Preliminary mechanism | In vitro | Raised in human monocytes in the lab after EPs 7630. | 48 |
L. Active compounds
| Connected to | Kind of connection | Evidence status | Context | Studies |
|---|---|---|---|---|
| Scopoletin (simple coumarin) | Biological association | In vitro | Tested in the lab for antibacterial activity; no clinical use as an isolated compound. Preparation or compound: root |
12 25 |
| Umbelliferone (7-hydroxycoumarin) | Biological association | Pharmacological theory | A 7-hydroxycoumarin, the type the EU report says is found in the extract; these lack the structure of anticoagulant coumarins. Presence in P. sidoides root specifically was not confirmed. Preparation or compound: root |
12 |
| Fraxetin (as fraxetin sulfate and fraxetin-7-O-glucoside) | Biological association | In vitro | Major constituents in an aqueous root extract by LC-MS (Schnitzler 2008, cited in the EU report). Coumarin sulfates appear confined to P. sidoides. Preparation or compound: root |
12 25 |
| Umckalin (7-hydroxy-5,6-dimethoxycoumarin) | Biological association | In vitro | With 6,8-dihydroxy-5,7-dimethoxycoumarin, the most active compounds against bacteria in a lab test (MIC 200-500 micrograms/ml); crude extract needed 5-7 mg/ml. Preparation or compound: root |
12 |
| Gallic acid | Biological association | In vitro | One of the few phenolics found in relatively high yield; named in the EU report as a pharmacologically active constituent; its methyl ester is also present. Preparation or compound: root |
12 |
| Epicatechin and catechin (flavan-3-ols) | Biological association | In vitro | Epicatechin was named as the bioactive marker compound of the P. sidoides part in a combination syrup (Park 2022); catechin is in the EU report list. CID given is epicatechin. Preparation or compound: root |
12 33 |
| Proanthocyanidins (prodelphinidins; oligomeric and polymeric) | Biological association | Pharmacological theory | Occur in high concentration, with catechin and gallocatechin units. The tannins may explain the mild gut upset, as the EU report suggests. Preparation or compound: root |
12 25 18 |
| Coumarin (reference compound) | Biological association | Authoritative guidance | The parent coumarin; in rodents it is liver-toxic through a pathway that humans mostly lack. Used here only to explain EU assessors' reasoning, not as a P. sidoides ingredient. Preparation or compound: not specific |
12 |
| Reniformin (diterpene) | Biological association | In vitro | A unique diterpene ester found in the root of the related species, not in P. sidoides. Preparation or compound: root of P. reniforme |
25 12 |
Each connection is stored with the ingredient, the connected record, the kind of connection, the evidence status, the supporting studies, the preparation or compound involved, and a review date (last reviewed October 25, 2026).
Evidence at a glance: what changed in 9 lab markers
Tap a number to show only those markers. Counts are markers, not people.
The evidence
The research centre for Pelargonium (Umckaloabo). Every record here was checked against PubMed or the publisher's page; we never list a study we have not verified.
Evidence by outcome
Bars show how many studies we found for each outcome, not how well it works. People are added up across trials only (reviews are not added, to avoid double counting).
How we rate evidence
High certainty
Several well-run trials or reviews agree; further research is unlikely to change the picture much.
Moderate certainty
Good trials point the same way, but some doubt remains.
Low certainty
Small, short or inconsistent trials. The finding could change with better research.
Very low certainty
Very little or very weak human data. Treat as a possibility only.
Mixed findings
Trials or reviews disagree with each other.
Not enough evidence
Not enough human research to say either way.
Evidence against
Good research found no benefit, or found harm.
We take the reviewers' own risk-of-bias and GRADE statements where they exist, and otherwise judge from study size, design, consistency, directness and whether a product matches what is sold. Many publications do not make evidence high. Method note: We searched PubMed and read the EU assessment report on Pelargonium root (EMA/HMPC/765656/2022, 2024) and the committee opinion in full, and recorded each study's design, people, product and result as reported. Only abstracts were read for most studies. Sources we could not find or open (NCCIH, LiverTox, LactMed, the FDA, the German Commission E text and the EU monograph annex itself) are marked not verified. Certainty ratings are the compiler's own reading unless a review gave its own. No study is cited that we could not verify.
Study library: every study we checked 48
| Study | Design | People | Product, dose, length | Result |
|---|---|---|---|---|
| Agbabiaka 2008 Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis Phytomedicine · PMID 18222667 · DOI |
Meta-analysis |
Adults and children with acute bronchitis; 6 RCTs, 4 pooled | Pelargonium sidoides extract (EPs 7630) root · vs placebo (5 trials), acetylcysteine (1 trial) |
Pooled placebo-controlled trials showed lower symptom scores with EPs 7630 by day 7. No serious adverse events reported. Methods, limits and fundingOutcomes: Bronchitis symptom scores at day 7 Limitations: Only four trials pooled; Jadad quality score; abstract gives no pooled numbers. Funding and conflicts: No funding statement read in the abstract record. Read: abstract |
| Alvero 2026 Short-term Liver Safety of Pelargonium sidoides DC. Root (PELARGO) 20 mg Capsule: A Non-interventional Post-authorization Safety Study Acta Med Philipp · PMID 41890334 · DOI |
Observational |
300 Adults with the common cold in Cavite, Philippines |
Pelargonium sidoides root 20 mg capsule (PELARGO), not EPs 7630 root 20 mg three times daily 7 days |
No signs or symptoms of liver toxicity and no serious events after 7 days. Dizziness, drowsiness, headache and increased appetite 1.3-2.0%. Methods, limits and fundingOutcomes: Signs and symptoms of liver injury Limitations: Short; no blood tests described in the abstract; no comparison group; company-run. Funding and conflicts: Two authors are employees of Pascual Laboratories, Inc. Read: abstract |
| Anheyer 2018 Herbal Medicine in Children With Respiratory Tract Infection: Systematic Review and Meta-Analysis Acad Pediatr · PMID 28610802 · DOI |
Meta-analysis |
2181 Children and adolescents with respiratory infections; 11 RCTs, 6 on Pelargonium |
Pelargonium sidoides root · vs placebo |
Responder rate RR 2.56 for Pelargonium; adverse events RR 1.06. Authors rate evidence as moderate for efficacy and safety. RR 2.56 (1.54 to 4.26) Methods, limits and fundingOutcomes: Responder rate; adverse events Limitations: Search to Feb 2015; heterogeneity in safety results (I2 72%). Funding and conflicts: No funding statement read. Read: abstract |
| Bachert 2009 Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial Rhinology · PMID 19382496 |
Controlled trial |
103 Adults with radiographically confirmed acute rhinosinusitis of presumed bacterial origin, SSS 12 or more |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 60 drops three times daily up to 22 days · vs placebo |
SSS fell 5.5 points with EPs 7630 vs 2.5 with placebo. Stopped early at the interim analysis after proof of efficacy. 3.0 points difference (2.0 to 3.9) Methods, limits and fundingOutcomes: Change in Sinusitis Severity Score (SSS) at day 7 Limitations: Small trial stopped early, which can overstate effect; dose was twice the bronchitis dose. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Bereznoy 2003 Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial Altern Ther Health Med · PMID 14526713 |
Controlled trial |
143 Children aged 6-10 with non-group-A-strep tonsillopharyngitis |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 20 drops three times daily 6 days · vs placebo |
TSS fell 7.1 +/- 2.1 with EPs 7630 (n=73) vs 2.5 +/- 3.6 with placebo (n=70). Authors say illness was shortened by at least 2 days. Difference about 4.6 points (unadjusted) (2.7 to 4.9 (adjusted difference, as printed)) Methods, limits and fundingOutcomes: Tonsillopharyngitis Severity Score (TSS), day 4 Limitations: The adverse-event counts in the abstract look inconsistent (4/73 vs 44/70) and are not relied on here. Industry-linked product. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Brendler 2008 A historical, scientific and commercial perspective on the medicinal use of Pelargonium sidoides (Geraniaceae) J Ethnopharmacol · PMID 18725280 · DOI |
Review |
Historical, scientific and commercial review of P. sidoides | Pelargonium sidoides root |
Describes traditional use in southern Africa and the commercial development of Stevens' Cure/Umckaloabo; says 18 clinical studies were reviewed. Methods, limits and fundingOutcomes: History and evidence summary Limitations: Narrative review. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Büttner 2023 Complementary and alternative medicine in the (symptomatic) treatment of acute tonsillitis in children: A systematic review Complement Ther Med · PMID 36868289 · DOI |
Systematic review |
Children with acute tonsillitis; 5 publications on complementary approaches | EPs 7630 and other complementary remedies root · vs various |
Studies pointed to symptom improvement and good tolerability, but quality and quantity were too low for reliable conclusions. Methods, limits and fundingOutcomes: Symptoms and tolerability Limitations: Five small studies only. Funding and conflicts: Authors declared grants from two foundations (Mahle, Christophorus). Read: abstract |
| Chuchalin 2005 Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial Explore (NY) · PMID 16781588 · DOI |
Controlled trial |
124 Adults with acute bronchitis for 48 hours or less, BSS 5 or more, six outpatient clinics |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 30 drops three times daily 7 days · vs placebo |
BSS fell 7.2 +/- 3.1 with EPs 7630 (n=64) vs 4.9 +/- 2.7 with placebo (n=60). Onset of effect within 4 days: 68.8% vs 33.3%. Adverse events 15/64 vs 10/60, all non-serious. Difference about 2.3 points (1.21 to 3.56) Methods, limits and fundingOutcomes: Change in BSS at day 7 Limitations: Small trial; planned interim analyses; industry-linked product. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). The abstract names the trade mark owner as Dr. Willmar Schwabe GmbH; Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Cinatl J Jr 2024 Multiple mechanisms enable broad-spectrum activity of the Pelargonium sidoides root extract EPs 7630 against acute respiratory tract infections Front Pharmacol · PMID 39469622 · DOI |
Review in-vitro |
Narrative review of mechanisms of EPs 7630 | EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root |
Describes antibacterial, antiviral, immune and barrier effects. Methods, limits and fundingOutcomes: Mechanisms Limitations: Narrative review. Funding and conflicts: Authors received a consultancy payment (literature support, proofreading); declaration also appears to relate to the manufacturer. Treat as industry-linked. Read: abstract |
| Conrad 2008 Extract of Pelargonium sidoides (EPs 7630) displays anti-infective properties by enhanced phagocytosis and differential modulation of host-bacteria interactions Planta Med · PMID 18240106 · DOI |
Review in-vitro |
In-vitro studies on phagocytes and group A streptococci | EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root |
Summarises lab studies of better immune-cell activity and altered bacteria-cell interaction. Methods, limits and fundingOutcomes: Phagocytosis; bacteria-host interaction Limitations: Short review of lab work. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Douros 2016 Herb-Induced Liver Injury in the Berlin Case-Control Surveillance Study Int J Mol Sci · PMID 26784183 · DOI |
Case control |
198 Hospital cases of liver injury in Berlin 2002-2011; 10 judged probable or possible herbal cause |
Various herbs; Pelargonium sidoides in 1 case root |
One case was judged possibly due to Pelargonium sidoides, among 10 herbal cases. Pattern mostly hepatocellular; no liver failure or death. Methods, limits and fundingOutcomes: Herbal cause of liver injury (CIOMS scale) Limitations: One case; 'possible' causality does not prove cause. Funding and conflicts: Not stated in the abstract. Read: abstract |
| European Medicines Agency 2024 Assessment report on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix (Final - Revision 2) European Medicines Agency · Source |
Regulatory assessment |
Regulatory review of traditional use, safety and clinical data | root |
Traditional use accepted for symptomatic treatment of common cold in adults and children from 3 years. Efficacy in acute bronchitis not accepted as well-established. Liver warning, pregnancy not recommended, no coumarin-anticoagulant interaction found. Methods, limits and fundingOutcomes: HMPC conclusions on use, safety, interactions, pregnancy Limitations: Regulatory text; the monograph annex itself was not separately read. Read: full-text |
| European Medicines Agency 2024 Opinion of the HMPC on a European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix (Revision 2) European Medicines Agency · Source |
Regulatory assessment |
Committee opinion | root |
Adopted 29 May 2024 by 23 of 27 votes. Finland, Ireland, Italy and the Netherlands recorded divergent positions: liver risk, and use in children under 12 or under 6. Methods, limits and fundingOutcomes: Vote and divergent positions Limitations: Opinion document only. Read: full-text |
| GBIF Secretariat 2026 GBIF Backbone: Pelargonium sidoides DC. GBIF · Source |
Database |
Taxonomy | root |
Accepted species, Geraniaceae, GBIF key 3827581. Methods, limits and fundingOutcomes: Accepted name Limitations: Database record. Read: full-text |
| GBIF Secretariat 2026 GBIF Backbone: Pelargonium reniforme (Andrews) Curtis GBIF · Source |
Database |
Taxonomy | root |
Accepted species, Geraniaceae, GBIF key 7268592. Methods, limits and fundingOutcomes: Accepted name Limitations: Database record. Read: full-text |
| Gökçe Ş 2021 Effectiveness of Pelargonium sidoides in pediatric patients diagnosed with uncomplicated upper respiratory tract infection: a single-blind, randomized, placebo-controlled study Eur J Pediatr · PMID 34304301 · DOI |
Controlled trial |
164 Children aged 1-18 with uncomplicated upper respiratory tract infection |
Liquid Pelargonium sidoides root extract root 7 days · vs placebo (single-blind) |
TSS fell 0.85 vs 0.62 points (p=0.018), a small difference. Cough frequency improved by day 3. Difference 0.23 points Methods, limits and fundingOutcomes: Total symptom score (TSS) Limitations: Single-blind; small difference; non-validated score (EU assessors set this study aside). Funding and conflicts: No funding statement in the abstract record. Read: abstract |
| Hoang 2023 Herbal Medicines for Rhinosinusitis: A Systematic Review and Network Meta-analysis Curr Allergy Asthma Rep · PMID 36609950 · DOI |
Meta-analysis |
People with rhinosinusitis or the common cold; 47 RCTs, 18 herbal medicines, network analysis with GRADE | Pelargonium sidoides and other herbs root · vs various |
For the common cold, Pelargonium sidoides had the best symptom effect (moderate certainty by the authors' GRADE). For acute post-viral rhinosinusitis, cineole and Pelargonium sidoides worked best for symptoms (moderate). Methods, limits and fundingOutcomes: Symptoms and quality of life Limitations: Indirect comparisons; abstract gives no numbers. Funding and conflicts: No funding statement read. Read: abstract |
| Honchar 2026 Pelargonium sidoides - from ethnopharmacology to evidence-based medicine: a systematic review Phytomedicine · PMID 41653615 · DOI |
Systematic review |
Review of botany, chemistry, mechanisms, cultivation and clinical data on P. sidoides | Pelargonium sidoides root preparations root |
Authors conclude clinical data support use in acute bronchitis, rhinosinusitis and tonsillopharyngitis; highlights coumarin sulfates and prodelphinidins. Methods, limits and fundingOutcomes: Narrative synthesis (PRISMA) Limitations: Narrative review; no pooled effect or evidence grade in the abstract. Funding and conflicts: No competing interests declared. Read: abstract |
| Kamin 2010 Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis - a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots Int J Clin Pharmacol Ther · PMID 20197012 · DOI |
Controlled trial |
200 Children and adolescents aged 1-18 with acute bronchitis outside the strict indication for antibiotics |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 1-6 y: 3x10 drops; >6-12 y: 3x20 drops; >12-18 y: 3x30 drops daily 7 days · vs placebo |
BSS improved 3.4 +/- 1.8 with EPs 7630 vs 1.2 +/- 1.8 with placebo (p<0.0001). Satisfaction 77.6% vs 25.8%. Adverse events all non-serious, similar between groups. Difference about 2.2 points Methods, limits and fundingOutcomes: Change in BSS day 0 to 7 Limitations: Mixed ages in one analysis (EU assessors criticised this). Industry-linked product. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Kamin 2010 Efficacy and tolerability of EPs 7630 in patients (aged 6-18 years old) with acute bronchitis Acta Paediatr · PMID 20070280 · DOI |
Controlled trial |
400 Children and adolescents aged 6-18 with acute bronchitis (dose-finding) |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 30, 60 or 90 mg extract per day (three groups) 7 days · vs placebo |
60 mg and 90 mg groups improved more than placebo; no relevant difference between those two doses. Cough, sputum and rales improved. Tolerability comparable to placebo. Methods, limits and fundingOutcomes: Change in BSS day 0 to 7 Limitations: The abstract gives no numbers for the BSS change. Industry-linked product. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Kamin 2012 Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents Pediatr Int · PMID 22360575 · DOI |
Controlled trial |
220 Children and adolescents aged 1-18 with acute bronchitis outside the strict indication for antibiotics |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 1-6 y: 3x10 drops; >6-12 y: 3x20 drops; >12-18 y: 3x30 drops daily 7 days · vs placebo |
BSS fell 4.4 +/- 1.6 with EPs 7630 vs 2.9 +/- 1.4 with placebo (p<0.0001), most for cough and rales. Tolerability similar in both groups. Difference about 1.5 points Methods, limits and fundingOutcomes: Change in BSS day 0 to 7 Limitations: Mixed ages in one analysis (EU assessors criticised this). Industry-linked product. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Kamin 2018 EPs 7630 is effective and safe in children under 6 years with acute respiratory tract infections: clinical studies revisited Curr Med Res Opin · PMID 29119837 · DOI |
Systematic review |
1067 Children under 6 with acute respiratory infections; 7 studies |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root · vs placebo in 2 RCTs; others uncontrolled |
Two double-blind trials in bronchitis showed better results than placebo. Uncontrolled studies in bronchitis, tonsillopharyngitis and rhinosinusitis showed improvement but cannot show cause. Methods, limits and fundingOutcomes: Symptom scores, recovery, safety Limitations: Only two controlled trials; others open-label, no comparison group. Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Kamin 2023 Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis Front Pediatr · PMID 36865690 · DOI |
Controlled trial |
591 Children aged 1-5 with acute bronchitis |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) as syrup or oral solution root syrup 2.5 ml three times daily or solution 10 drops three times daily 7 days · vs syrup vs solution (no placebo) |
Few adverse events: infections 7.2% (syrup) and 7.4% (solution); stomach and gut complaints 2.7% and 3.2%. More than 90% improved or recovered on the short bronchitis scale. EU assessors report liver enzymes: at least one raised in 4.1% at the end vs 5.7% at the start. No placebo, so no effect size (Liver enzyme rise 4.1% (2.6-6.0) at end vs 5.7% (3.9-7.9) at baseline (EMA report)) Methods, limits and fundingOutcomes: Safety and tolerability (primary); BSS-ped Limitations: Open-label; no placebo group, so it cannot show benefit; manufacturer-funded. Funding and conflicts: Funded by Willmar Schwabe GmbH & Co. KG; funder involved in study design, analysis and writing; two authors are Schwabe employees. Read: abstract |
| Kardos 2022 Effects of Pelargonium sidoides extract EPs 7630 on acute cough and quality of life - a meta-analysis of randomized, placebo-controlled trials Multidiscip Respir Med · PMID 36051888 · DOI |
Meta-analysis |
2195 Adults and children with acute bronchitis or common cold; 11 placebo-controlled RCTs |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 5-7 days · vs placebo |
Adults with bronchitis, day 7: 88.7% vs 47.6% had at least 50% less cough (RR 2.13); no cough 26.0% vs 6.3% (RR 5.00). Children/adolescents with bronchitis, day 7: 79.6% vs 41% (RR 1.86); no cough 18.0% vs 5.5% (RR 2.91). Common cold, day 5: 56.8% vs 38.8% (RR 1.40). RR 1.40 to 5.00 depending on group (Adult bronchitis response RR 2.13 (1.37-3.31); cough gone RR 5.00 (3.10-8.07)) Methods, limits and fundingOutcomes: Cough intensity reduction of at least 50%; cough remission; quality of life Limitations: Pools mostly manufacturer-linked trials; no risk-of-bias rating or GRADE in the abstract. Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. No separate funding statement was found in the record. Read: abstract |
| Kolodziej 2007 Fascinating metabolic pools of Pelargonium sidoides and Pelargonium reniforme, traditional and phytomedicinal sources of the herbal medicine Umckaloabo Phytomedicine · PMID 17188477 · DOI |
Review in-vitro |
Chemistry of P. sidoides and P. reniforme | Pelargonium sidoides and P. reniforme roots root |
Both roots hold simple coumarins and polyphenols. Coumarin sulfates and glycosides appear confined to P. sidoides; the diterpene reniformin was found in P. reniforme roots. Both contain proanthocyanidins. Methods, limits and fundingOutcomes: Compound inventory Limitations: Review; no clinical data. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Lizogub 2007 Efficacy of a pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial Explore (NY) · PMID 18005909 · DOI |
Controlled trial |
103 Adults with the common cold, symptoms for 24-48 hours |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 30 drops three times daily up to 10 days · vs placebo |
SSID improved 14.6 +/- 5.3 vs 7.6 +/- 7.5 (p<0.0001). Clinically cured at day 10: 78.8% vs 31.4%. Work absence 6.9 vs 8.2 days. Adverse events 3/103, none serious. Cure 78.8% vs 31.4% Methods, limits and fundingOutcomes: Sum of symptom intensity differences (SSID) of the Cold Intensity Score, day 1-5 Limitations: Small; one country; industry-linked product; symptom scoring by patients. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Matthys 2003 Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial Phytomedicine · PMID 12807337 · DOI |
Controlled trial |
468 Adults with acute bronchitis for 48 hours or less, Bronchitis Severity Score (BSS) 5 or more, 36 primary care practices |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 30 drops three times daily 7 days · vs placebo |
BSS fell 5.9 +/- 2.9 points with EPs 7630 (n=233) and 3.2 +/- 4.1 with placebo (n=235). Inability to work fell to 16% vs 43%. Adverse events 20/233 vs 16/235, all non-serious. Difference in BSS change about 2.7 points (-3.359 to -2.060 (difference EPs 7630 minus placebo, as printed)) Methods, limits and fundingOutcomes: Change in BSS at day 7 Limitations: Industry-linked product; trial design was multi-stage adaptive; symptom score is self-rated; short. Funding and conflicts: No funding statement in the abstract record that was read. The EU assessment report (HMPC, 2024) states that the main placebo-controlled trials were run by the same investigators (the manufacturer) and in the same region (Ukraine and Russia). Read: abstract |
| Matthys 2013 Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD Respir Med · PMID 23478193 · DOI |
Controlled trial |
200 Adults with COPD stage II/III on standard treatment |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) as add-on root 30 drops three times daily 24 weeks · vs placebo (n=101); active n=99 |
Median time to first exacerbation 57 days with EPs 7630 vs 43 days with placebo (p=0.005, one-sided test). Fewer exacerbations and fewer patients using antibiotics. More minor gut adverse events with EPs 7630. 14 days longer (median) Methods, limits and fundingOutcomes: Time to first COPD exacerbation Limitations: Single trial; one-sided test; short for a chronic disease; not independently repeated. Funding and conflicts: Trial registered ISRCTN01681733. No funding statement read in the abstract record; the manufacturer-linked pattern in this research area applies. Read: abstract |
| Matthys 2018 Pelargonium sidoides preparation EPs 7630 in COPD: health-related quality-of-life and other patient-reported outcomes in adults receiving add-on therapy Curr Med Res Opin · PMID 29231073 · DOI |
Controlled trial |
199 Adults with COPD stage II/III (secondary analysis of the 24-week trial) |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) as add-on root 24 weeks · vs placebo |
All quality-of-life and patient-reported measures improved more with EPs 7630 than placebo (SGRQ total p<0.001). The SGRQ gap exceeded the 4-point minimal important difference. SGRQ gap above 4 points Methods, limits and fundingOutcomes: Quality of life (SGRQ, EQ VAS), cough and sputum scores, work absence Limitations: Re-analysis of the same single trial, not a new study. Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Matthys 2023 Effects of EPs 7630 on the duration of inability to work in acute bronchitis - a meta-analysis Multidiscip Respir Med · PMID 37476531 · DOI |
Meta-analysis |
1011 Adults with acute bronchitis; 4 double-blind placebo-controlled RCTs |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root marketed dose 7 days · vs placebo |
Share still unable to work after a week: 14-19% with EPs 7630 vs 41-55% with placebo (RR 0.35). About 1.73 fewer sick days. RR 0.35; 1.73 days fewer (RR 0.26-0.45; days 1.17-2.29) Methods, limits and fundingOutcomes: Days unable to work; share still unable to work after 7 days Limitations: Only four trials, all of the same product; work absence is partly self-reported. Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Moyo 2014 Medicinal properties and conservation of Pelargonium sidoides DC J Ethnopharmacol · PMID 24463034 · DOI |
Review |
Review of medicinal properties and conservation of P. sidoides | Pelargonium sidoides root |
Lab work suggests effects on microbe binding and host defence rather than direct killing. Says safety evaluation data are lacking and wild populations are overharvested in places. Methods, limits and fundingOutcomes: Narrative synthesis Limitations: Narrative review. Funding and conflicts: Not stated in the abstract. Read: abstract |
| NCBI 2026 NCBI Taxonomy: Pelargonium sidoides (taxid 1417791) NCBI Taxonomy · Source |
Database |
Taxonomy | root |
Species, eudicots, taxid 1417791. Methods, limits and fundingOutcomes: Species record Limitations: Database record. Read: full-text |
| Park 2022 Evaluation of food effects on the pharmacokinetics of Pelargonium sidoides and Coptis with each bioactive compound berberine and epicatechin after a single oral dose of an expectorant and antitussive agent UI026 in healthy subjects Transl Clin Pharmacol · PMID 35419311 · DOI |
Controlled trial |
12 12 healthy men, fed vs fasted |
UI026, a combination of Pelargonium sidoides and Coptis extracts (not EPs 7630) root single 27 ml syrup dose single dose · vs fed vs fasted |
Food lowered epicatechin Cmax by about 29% and AUC by about 45% (not statistically significant) and berberine Cmax by 33% and AUC by 67%. Epicatechin AUC about 45% lower when fed Methods, limits and fundingOutcomes: Blood levels of epicatechin and berberine Limitations: Combination product with Coptis; 12 men; single dose. Funding and conflicts: Authors declared nothing to declare. Read: abstract |
| Patiroglu 2012 The efficacy of Pelargonium sidoides in the treatment of upper respiratory tract infections in children with transient hypogammaglobulinemia of infancy Phytomedicine · PMID 22809962 · DOI |
Controlled trial |
28 Children with transient hypogammaglobulinemia of infancy during an upper respiratory infection |
Pelargonium sidoides extract root 1 week · vs placebo |
Appetite increased. Benefit for congestion and cough was not significant. Lab tests were measured before and after; the abstract does not report any change. Methods, limits and fundingOutcomes: Symptom recovery; blood count, clotting and liver tests before and after Limitations: Pilot with 14 vs 14 children; underpowered. Funding and conflicts: No funding statement in the abstract record. Read: abstract |
| Perić 2020 Herbal Drug EPs 7630 versus Amoxicillin in Patients with Uncomplicated Acute Bacterial Rhinosinusitis: A Randomized, Open-Label Study Ann Otol Rhinol Laryngol · PMID 32456442 · DOI |
Controlled trial |
50 Adults with uncomplicated acute bacterial rhinosinusitis |
EPs 7630 tablets root 20 mg three times daily 10 days · vs amoxicillin 500 mg three times daily |
Greater improvement with EPs 7630 than amoxicillin for total symptom score, nasal obstruction, facial pain, smell, endoscopy score (p<0.001 each). No difference for runny nose or postnasal drip. No adverse events reported in either group. Methods, limits and fundingOutcomes: Total symptom score, endoscopy, bacterial culture Limitations: Open-label, only 50 patients, single country; no placebo. Funding and conflicts: No funding statement in the abstract record. Read: abstract |
| Riley 2019 Treatment with EPs 7630, a Pelargonium Sidoides Root Extract, Is Effective and Safe in Patients with the Common Cold: Results From a Randomized, Double Blind, Placebo-Controlled Clinical Trial Integr Med (Encinitas) · PMID 31341433 |
Controlled trial |
105 Adults with the common cold |
EPs 7630 film-coated tablet root 40 mg three times daily 10 days · vs placebo |
SSID 12.5 +/- 4.4 vs 8.8 +/- 6.8. Clinical cure (CIS = 0) at day 10: 45% vs 12%. Adverse events mild: 9.4% vs 13.5%. Cure 45% vs 12% Methods, limits and fundingOutcomes: SSID of Cold Intensity Score, day 1-5 Limitations: Small; industry-linked; one trial. Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Roth 2019 Pelargonium sidoides radix extract EPs 7630 reduces rhinovirus infection through modulation of viral binding proteins on human bronchial epithelial cells PLoS One · PMID 30707726 · DOI |
Laboratory research in-vitro |
18 Bronchial epithelial cells from people with severe asthma (6), COPD (6) and healthy controls (6), grown in the lab |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root concentration-dependent 3 days · vs untreated cells |
EPs 7630 improved cell survival after rhinovirus infection and changed levels of some host proteins (lower ICOS, ICOSL, C1qR; higher beta-defensin-1 and SOCS-1). Methods, limits and fundingOutcomes: Cell survival after rhinovirus; virus-binding proteins Limitations: Cells in a dish; small number of donors. Funding and conflicts: No competing interests declared. Read: abstract |
| Schapowal 2019 Treatment of signs and symptoms of the common cold using EPs 7630 - results of a meta-analysis Heliyon · PMID 31844762 · DOI |
Meta-analysis |
833 Adults with the common cold; 5 double-blind placebo-controlled trials |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 10 days · vs placebo |
CIS reduction larger with EPs 7630 at day 5 (MD -2.30) and day 10 (MD -1.16). Complete remission RR 2.52 at day 5 and 2.13 at day 10. Fewer missed work days and less paracetamol. No serious reactions. MD -2.30 (day 5); -1.16 (day 10) (day 5: -4.12 to -0.49; day 10: -2.22 to -0.10) Methods, limits and fundingOutcomes: Cold Intensity Score (CIS) Limitations: Pools five trials of one product; heterogeneity large at day 5 (wide interval). Funding and conflicts: Authors' affiliations or declarations in the record link to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Read: abstract |
| Seifert 2019 Faster recovery and reduced paracetamol use - a meta-analysis of EPs 7630 in children with acute respiratory tract infections BMC Pediatr · PMID 31014293 · DOI |
Meta-analysis |
523 Children aged 6-10 with non-strep tonsillopharyngitis (3 trials) or acute bronchitis (3 trials) |
EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root 6-7 days · vs placebo |
Less paracetamol with EPs 7630 in 5 of 6 trials (about 244 mg less on average). Still unable to attend school at treatment end: 30.2% vs 74.4% (RR 0.43). Hedges g -0.28; RR 0.43 (g: -0.53 to -0.02; RR 0.29-0.65) Methods, limits and fundingOutcomes: Cumulative paracetamol use; ability to attend school at treatment end Limitations: Uses individual participant data from manufacturer-linked trials; six small trials. Funding and conflicts: Authors received honoraria from Dr. Willmar Schwabe GmbH. Read: abstract |
| Stammschulte 2012 Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained? Regul Toxicol Pharmacol · PMID 22728685 · DOI |
Other |
Letter commenting on the 2012 re-assessment (Teschke and colleagues) | Pelargonium sidoides root |
Title questions whether causality was adequately ascertained. The abstract record has no text; only the title and authors were read. Methods, limits and fundingOutcomes: Comment Limitations: Only a title record was available. Funding and conflicts: Not stated. Read: summary-only |
| Sütçü 2024 Hand, foot, and mouth disease: could EPs® 7630 be a treatment option? A prospective randomized open-label multicenter clinical study Front Pediatr · PMID 38832001 · DOI |
Controlled trial |
208 Children with hand, foot and mouth disease within 48 h of onset |
EPs 7630 root · vs no EPs 7630 (control group, open label) |
Mean illness 6.07 vs 8.58 days (p<0.001). Fewer hospitalisations (p=0.019). Only side effect: unpleasant taste in 5 children. 2.5 days shorter Methods, limits and fundingOutcomes: Complaint scores; disease length; hospitalisation Limitations: Open-label, no placebo; outcomes can be biased by knowing the treatment. Funding and conflicts: Authors declared no commercial conflict. Read: abstract |
| Tahan 2013 Can the Pelargonium sidoides root extract EPs® 7630 prevent asthma attacks during viral infections of the upper respiratory tract in children? Phytomedicine · PMID 23142309 · DOI |
Controlled trial |
61 Children with asthma who had a viral upper respiratory infection |
Pelargonium sidoides (EPs 7630) root 5 days · vs no treatment (open, not placebo) |
Fewer asthma attacks and less cough and congestion in the Pelargonium group (p<0.05). No difference for fever or muscle aches. Methods, limits and fundingOutcomes: Asthma attack after 5 days; symptoms Limitations: Small; control group got no treatment, not placebo; abstract gives no attack counts. Funding and conflicts: No funding statement in the abstract record. Read: abstract |
| Teschke 2012 Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol · PMID 22381150 · DOI |
Case series |
15 15 spontaneous reports of suspected liver injury attributed to P. sidoides, re-assessed with the CIOMS scale |
Pelargonium sidoides products root |
In none of 15 cases was causality highly probable or probable. Many had other explanations and poor data. Methods, limits and fundingOutcomes: Causality (CIOMS/RUCAM-type scale) Limitations: Reassessment of reports, not a new study. Author is a recognised herbal hepatotoxicity researcher; funding not stated in the abstract. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Teschke 2012 Initially purported hepatotoxicity by Pelargonium sidoides: the dilemma of pharmacovigilance and proposals for improvement Ann Hepatol · PMID 22700632 |
Case series |
13 13 spontaneous reports of suspected liver injury from P. sidoides, re-assessed |
Pelargonium sidoides products root |
None of 13 cases had causality for P. sidoides established; confounders included other drugs, pancreatitis, cholangitis, viral hepatitis, autoimmune hepatitis and pre-existing liver disease. Methods, limits and fundingOutcomes: Causality Limitations: Reassessment of reports. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Teschke 2013 Herbal hepatotoxicity: suspected cases assessed for alternative causes Eur J Gastroenterol Hepatol · PMID 23510966 · DOI |
Systematic review |
573 23 published case series on suspected herbal liver injury |
Various herbs including P. sidoides root |
Alternative causes were found in 48.5% of 573 cases initially thought to be herbal liver injury. Methods, limits and fundingOutcomes: Alternative causes Limitations: General herb review; Pelargonium was one search term. Funding and conflicts: Not stated in the abstract. Read: abstract |
| Timmer 2013 Pelargonium sidoides extract for treating acute respiratory tract infections Cochrane Database Syst Rev · PMID 24146345 · DOI |
Systematic review |
Children and adults with acute respiratory tract infections; 10 eligible trials, 8 analysed | Pelargonium sidoides preparations (mostly EPs 7630), liquid and tablet root · vs placebo or other treatment |
Three adult bronchitis trials (746 patients) and three child bronchitis trials (819 children): effective for most outcomes with the liquid form, not with tablets; not pooled because of differences. One sinusitis trial (n=103): complete resolution at day 21 RR 0.43. One common-cold trial: benefit at 10 days, not at 5 days. Adverse events more common with P. sidoides, none serious. Sinusitis RR 0.43 (0.30 to 0.62) Methods, limits and fundingOutcomes: Complete resolution of symptoms; key symptoms Limitations: Authors rated evidence low (bronchitis) and very low (sinusitis, common cold). Publication bias suspected from the funnel plot. Funding and conflicts: Cochrane review; one author declared a debate sponsored by Dr. Willmar Schwabe GmbH. Review authors state the trials were investigator-initiated. Read: full-text |
| Wagner 2015 Herbal Medicine for Cough: a Systematic Review and Meta-Analysis Forsch Komplementmed · PMID 26840418 · DOI |
Meta-analysis |
7083 Adults and children with cough in upper respiratory infection or common cold; 34 RCTs across several herbs, 11 on Pelargonium |
Pelargonium sidoides (11 RCTs) among other herbs root · vs mostly placebo |
Authors called the Pelargonium evidence moderate: RR 4.60 for cough relief vs placebo. RR 4.60 (2.89 to 7.31) Methods, limits and fundingOutcomes: Cough frequency and severity Limitations: Search only to March 2012; mixes many herbs. Funding and conflicts: No funding statement read. Read: abstract |
| Witte 2015 The Pelargonium sidoides Extract EPs 7630 Drives the Innate Immune Defense by Activating Selected MAP Kinase Pathways in Human Monocytes PLoS One · PMID 26406906 · DOI |
Laboratory research in-vitro |
Human blood immune cells in the lab | EPs 7630 (ethanol-water extract of Pelargonium sidoides root; also called Umckaloabo) root dose-response in cell culture · vs untreated cells |
EPs 7630 made human monocytes release TNF-alpha, IL-6 and IL-10 through MAP kinases; T-cells did not respond. A second stimulus then gave a different cytokine pattern. Methods, limits and fundingOutcomes: Cytokine production; MAP kinase activation Limitations: Cell experiments only; cannot show effects in patients. Funding and conflicts: Manufacturer supplied the extract and support. Read: abstract |
What we do not know yet
- What the evidence supports: symptom scores fall more than placebo over about a week in bronchitis and colds (low or very low certainty; mixed for colds).
- What is uncertain: the trials are mostly linked to one manufacturer and region, the Cochrane review suspected publication bias, and EU regulators did not accept bronchitis benefit as proven.
- What is missing: independent trials, long-term safety, studies in liver or kidney disease and in people taking warfarin.
- How common liver injury is has not been measured.
- Pregnancy and breastfeeding safety has not been studied.
- Other Pelargonium species and combination products have almost no trial data.
- No mind, mood or sleep studies exist.
How new research is added
New studies are found by a saved PubMed search and are placed in a review queue. A person reads each one before it changes any evidence rating or safety wording. New publications never change ratings automatically.
Lab markers
What changed in blood or saliva tests during trials. A changed number is not the same as feeling or being healthier, and we give no "normal ranges".
Organ function 1
Liver enzymes ALT and AST (safety monitoring)
No clear change in trials
Blood enzymes released when liver cells are damaged. High values (above 5 times the upper limit of normal for ALT) point to liver injury.
Low certaintyResults and what it means
Why it was measured
Included as a safety check, not as a benefit. Regulators watch it because of reported liver cases.
Statistical vs. clinical meaning
Short courses (7 days), no placebo in the large study. Does not rule out rare individual reactions.
Safety implication
Rare liver injury cases have been reported; see Safety tab.
| Study | Result | People | Product |
|---|---|---|---|
| 12 | In 591 children aged 1-5 (Kamin 2023), at least one liver enzyme was raised in 4.1% at the end of 7 days vs 5.7% at the start; all raises were under 5 times the upper limit; no upward shift of mean values. | 591 children aged 1-5 with bronchitis | EPs 7630 syrup or solution, 7 days |
| 34 | Liver enzymes were measured before and after one week, but the abstract does not report any change. | 28 children | Pelargonium sidoides extract |
Other 8
Bronchitis Severity Score (BSS)
Lowered in trials
A symptom score that adds up cough, sputum, rales (crackles heard by the doctor), chest pain on coughing and shortness of breath.
Low certaintyResults and what it means
Why it was measured
It is the main outcome in the bronchitis trials.
Statistical vs. clinical meaning
Statistically clear, but the EU committee judged that a 4-point (adults) or 3-point (children) gap would be strongly clinically relevant, and none of the trials reached it.
Safety implication
None; it is a symptom score, not a safety test.
| Study | Result | People | Product |
|---|---|---|---|
| 27 | Fell 5.9 +/- 2.9 points with EPs 7630 vs 3.2 +/- 4.1 with placebo at day 7 | 468 adults | EPs 7630 30 drops three times daily |
| 8 | Fell 7.2 +/- 3.1 vs 4.9 +/- 2.7 points at day 7 | 124 adults | EPs 7630 30 drops three times daily |
| 19 | Improved 3.4 +/- 1.8 vs 1.2 +/- 1.8 points | 200 children and teens | EPs 7630 age-based drops |
| 21 | Fell 4.4 +/- 1.6 vs 2.9 +/- 1.4 points | 220 children and teens | EPs 7630 age-based drops |
St George's Respiratory Questionnaire (SGRQ) total score
Lowered in trials
A questionnaire on how much a lung disease affects daily life. Lower scores mean a better quality of life.
Very low certaintyResults and what it means
Why it was measured
It shows whether COPD treatment improves how people feel and function.
Statistical vs. clinical meaning
One trial's secondary analysis.
Safety implication
None.
| Study | Result | People | Product |
|---|---|---|---|
| 29 | SGRQ total improved more with EPs 7630 than placebo (p<0.001); the gap exceeded the 4-point minimal important difference. Exact scores are not in the abstract. | 199 adults with COPD stage II/III | EPs 7630 add-on for 24 weeks |
Days unable to work
Lowered in trials
The number of days a patient could not work because of bronchitis symptoms.
Low certaintyResults and what it means
Why it was measured
A practical outcome people care about.
Statistical vs. clinical meaning
Practical but self-reported and short illness.
Safety implication
None.
Time to first COPD exacerbation
Lowered in trials
How many days pass before a COPD flare-up needing extra treatment.
Very low certaintyResults and what it means
Why it was measured
Flare-ups drive hospital stays and lung decline.
Statistical vs. clinical meaning
One trial; one-sided test.
Safety implication
More minor gut adverse events with EPs 7630.
| Study | Result | People | Product |
|---|---|---|---|
| 28 | Median 57 days with EPs 7630 vs 43 days with placebo (p=0.005, one-sided) | 200 adults, COPD stage II/III | EPs 7630 add-on, 24 weeks |
Cold Intensity Score (CIS)
Lowered in trials
A 10-symptom score (runny nose, sore throat, congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, fever).
Mixed findingsResults and what it means
Why it was measured
Main outcome in common cold trials.
Statistical vs. clinical meaning
Small differences in a self-rated score; the illness resolves anyway.
Safety implication
None.
| Study | Result | People | Product |
|---|---|---|---|
| 26 | CIS fell 10.4 +/- 3.0 vs 5.6 +/- 4.3 points by day 5; cured at day 10 78.8% vs 31.4% | 103 adults | EPs 7630 30 drops three times daily |
| 36 | SSID 12.5 +/- 4.4 vs 8.8 +/- 6.8; CIS 0 at day 10 in 45% vs 12% | 105 adults | EPs 7630 40 mg tablet three times daily |
| 38 | CIS mean difference -2.30 at day 5 (95% CI -4.12 to -0.49), -1.16 at day 10 (-2.22 to -0.10) | 833 adults in 5 trials | EPs 7630 |
Sinusitis Severity Score (SSS)
Lowered in trials
A 0-24 point score of nose and sinus symptoms and signs.
Low certaintyResults and what it means
Tonsillopharyngitis Severity Score (TSS)
Lowered in trials
A score of sore throat, difficulty swallowing and tonsil findings.
Very low certaintyClotting tests (Quick/PTT)
No clear change in trials
Blood tests showing how quickly blood clots.
Low certaintyResults and what it means
Why it was measured
Pelargonium roots contain coumarins, so regulators asked whether the extract affects blood clotting.
Statistical vs. clinical meaning
Short use in people not on anticoagulants; the EU report notes no case in trials proving increased bleeding. Mild bleeding events (nose, gum) are listed as undesirable effects.
Safety implication
People on warfarin or similar drugs should still ask a doctor or pharmacist.
| Study | Result | People | Product |
|---|---|---|---|
| 12 | In two adult bronchitis trials (Matthys 2003, Chuchalin 2005) clotting tests did not differ between EPs 7630 and placebo (as summarised in the EU assessment report). | Adults with acute bronchitis | EPs 7630 for 7 days |
Safety
What studies and official sources say about side effects, medicines and who should check first. Each point shows what kind of evidence it comes from.
Main points to know 6
- Liver injury has been reported; stop and see a doctor if signs appear. Germany's medicines agency (BfArM) had 30 spontaneous reports of liver problems (11 hepatitis, 8 jaundice, 3 liver injury) linked to Pelargonium products up to June 2012, and one person with hepatitis needed a liver transplant. It judged an association at least possible and had warnings added to German product information. Two re-assessments by Rolf Teschke's group of 15 and 13 reports found that none met the 'probable' bar, because of other explanations (other drugs, viral or autoimmune hepatitis, pancreatitis or bile duct disease) and poor data. A Berlin hospital study found one 'possible' Pelargonium case among 198 liver injuries. The EU committee kept a warning: if signs of liver trouble appear (dark urine, yellow skin or eyes, severe tiredness, upper right belly pain), stop and see a doctor. Finland formally disagreed with the EU monograph because of liver risk. EU safety updates for 2013-2023 counted 1,097 reports of all kinds, with 9 serious liver or bile cases, and judged the balance of benefit and risk unchanged. How common liver injury is cannot be worked out from these reports. Case series 12 43 44 11 2 13
- Bleeding and blood thinners: the roots contain coumarins, but the data are reassuring only for short use. Pelargonium roots contain simple coumarins, so regulators asked whether the extract could thin the blood or boost warfarin-type drugs. In rats, EPs 7630 did not change clotting times and did not change warfarin's effect or levels. The coumarins found in the extract lack the chemical features of anticoagulant coumarins. In two adult trials, clotting tests did not differ from placebo, and the EU report found no trial case that clearly proved extra bleeding. Even so, nose bleeds and gum bleeding are listed as undesirable effects (frequency not known). There are no studies in people taking warfarin. Anyone on blood thinners, or with a bleeding disorder, should ask a doctor or pharmacist first. Note that some trials excluded people with a tendency to bleed. Authoritative guidance 12 27 8
- Pregnancy and breastfeeding: not recommended. The EU assessment says safety in pregnancy and breastfeeding has not been established, there is no fertility or developmental toxicity data, and use is not recommended. No human pregnancy study was found. Authoritative guidance 12
- Allergic reactions can occur, including rare severe ones. The WHO monitoring centre in Uppsala received 34 allergy reports (2002-2006, all from Germany) for the ethanol root extract. In 15, rash, itching, hives, swelling and sometimes breathing difficulty or circulatory failure suggested an immediate-type allergy. Two people needed emergency treatment. Anyone who has reacted should not take it again. Case report 12
- Most trial evidence is industry-linked and short. The EU committee noted that the main placebo-controlled trials were done by the same investigators (the manufacturer) mostly in Ukraine and Russia. Many meta-analyses and safety papers carry author links to Dr. Willmar Schwabe GmbH, the maker of EPs 7630. Safety data cover mostly 7 to 10 days of use, with one 24-week COPD trial. Rare harms and long-term effects remain unknown. Authoritative guidance 12 46 23 39
- Children: regulators disagree. The EU monograph accepts traditional use for the common cold in adults and children from 3 years, but not under 3 years. Ireland objected to use under 12 without a doctor, and Italy and the Netherlands said liver safety evidence is not enough for children under 6. A large open-label trial in 591 children aged 1-5 found few side effects and no rise in liver enzymes over 7 days, but it had no placebo group and the maker funded it. Authoritative guidance 13 12 23 22
Side effects 6
| Effect | How often | Severity and recovery | Evidence |
|---|---|---|---|
| Mild stomach and gut upset: diarrhoea, stomach pain, nausea, vomiting Listed in the EU monograph as 'frequency not known'. In the COPD trial gut events were more common than with placebo. In 591 young children, gut events were 2.7-3.2%. | Not established | mild usually goes away on its own | Controlled trial 12 28 23 |
| Hypersensitivity: rash, itching, hives, swelling of lips or tongue, anaphylaxis 34 allergy reports to the WHO centre, 15 suggestive of type I allergy, two needing emergency care. | Not established | moderate to severe treated with antihistamines and steroids in reported cases | Case report 12 |
| Nosebleed and gum bleeding Listed as 'frequency not known'; in a pooled safety review gum bleeding and nosebleeds were slightly more frequent than with placebo. | Not established | mild not reported | Authoritative guidance 12 |
| Liver disorders and hepatitis Listed as 'frequency not known'. | Not established | serious in rare cases varied; one liver transplant among the first 30 German reports | Case series 12 43 44 |
| Dizziness, drowsiness, headache, increased appetite The Philippine product is a root capsule, not EPs 7630. Increased appetite also seen in the small pilot in children. | 1.3 to 2.0% in a 300-patient company-run safety study (Philippines, 7 days, root capsule) | mild resolved spontaneously | Controlled trial 2 34 |
| Unpleasant taste Single small study. | 5 of 94 children in one open-label trial | mild transient | Controlled trial 41 |
Liver
The signal is real but unsettled. Germany's agency (BfArM) judged at least a possible link after 30 reports and added a warning; the EU kept this warning, put the herb on the list for regular safety updates, and reviewed 1,097 reports from 2013 to 2023, including 9 serious liver or bile cases, concluding that benefit still outweighs risk when used as approved. On the other hand, two re-assessments of earlier reports by one academic group found no case with probable cause, and a 300-person post-marketing study and a large children's trial found no liver signal over 7 days. EU assessors note no studies in people with liver or kidney disease, and an Italian report suggests alcohol-free preparations for people with a history of liver disease. Rare idiosyncratic reactions cannot be excluded. 12 43 44 40 11 45 2 23 13
How often. Not known. The EU monograph lists liver disorders and hepatitis as 'frequency not known'. EU safety updates counted 9 serious cases against several million patient-days of exposure over 10 years, but reporting is incomplete, so this is not a true rate.
Monitoring. No routine blood testing is recommended in the monograph. Stop the product and see a doctor if yellow eyes or skin, dark urine, pale stools, severe tiredness, loss of appetite or upper right belly pain appear.
- BfArM (Germany) via EU assessment.
- Teschke et al. 2012 (Regul Toxicol Pharmacol).
- Teschke 2012 (Ann Hepatol).
- Berlin Case-Control Surveillance Study (2016).
- Italian pharmacovigilance case (EU report).
This is a safety connection. It is not evidence that Pelargonium (Umckaloabo) supports liver health.
Medicines and supplements 6
| With | Why it matters | Importance | Evidence | What to do |
|---|---|---|---|---|
| Warfarin, acenocoumarol and other coumarin-type anticoagulants drug | Roots contain simple coumarins; theory says they might add to anticoagulant effect. The coumarins found do not have the structure needed for anticoagulation. | Unclear. Rat study: no effect on clotting or on warfarin effect or levels. Two adult trials: no clotting differences. No study in people taking warfarin. | Animal research Not enough evidence 12 27 8 | Tell your doctor or pharmacist before using; if you take warfarin, get clotting checks if you start. |
| Antiplatelet drugs and other blood thinners (aspirin, clopidogrel, new oral anticoagulants) drug | Not studied. Nosebleeds and gum bleeding are listed side effects. | Unknown. | Pharmacological theory Not enough evidence 12 | Ask a doctor or pharmacist. |
| Penicillin V (antibiotic) drug | Pharmacokinetic check of blood levels. | In 28 healthy volunteers over 7 days, EPs 7630 did not significantly change penicillin V levels (EU report, summarising Conrad and Schulz 2007). | Controlled trial Low certainty 12 | No dose change expected for penicillin V; other antibiotics were not tested. |
| Other medicines that can harm the liver, and alcohol drug | Many spontaneous liver reports involved other medicines taken at the same time (19 of 30 in the German series). | Unknown; no interaction study. The liquid extract contains ethanol (about 11%). | Case series Not enough evidence 12 43 | Avoid combining with other liver-stressing medicines or heavy alcohol unless a doctor agrees; consider alcohol-free forms if you have a liver history. |
| Immunosuppressants and immune-modulating medicines drug | In lab dishes the extract activated human monocytes and released inflammatory messengers. | No human interaction data. Clinical relevance unknown. | Laboratory research Not enough evidence 48 | Ask your specialist before use. |
| Drugs handled by liver enzymes (CYP system) drug | The EU report says specific data on interactions are not available. | No CYP interaction study was found. | Pharmacological theory Not enough evidence 12 | Ask a pharmacist if you take narrow-margin drugs. |
Who should check first 8
| Situation | Advice | Evidence |
|---|---|---|
| Known allergy to Pelargonium preparations | Do not use. EU contraindication: hypersensitivity. | Authoritative guidance 12 |
| Pregnancy and breastfeeding | Not recommended; safety not established. | Authoritative guidance 12 |
| Liver disease, or a past episode of liver injury | No safety studies in liver disease. Avoid unless a doctor agrees; consider alcohol-free forms. | Authoritative guidance 12 13 |
| Kidney disease | No safety studies in kidney disease. Ask a doctor. | Authoritative guidance 12 |
| Bleeding disorder or taking blood thinners | Ask a doctor first. Key trials excluded people with a bleeding tendency. | Authoritative guidance 12 |
| Children under 3 (EU monograph); caution under 6 or 12 (divergent national views) | Not recommended by the EU monograph under 3 years. Ireland, Italy and the Netherlands recorded objections to use in younger children. | Authoritative guidance 12 13 |
| Alcohol-sensitive people (liquid extracts contain ethanol) | Liquid preparations contain ethanol, which may affect driving; consider alcohol-free forms. | Authoritative guidance 12 |
| Severe or lasting chest infection, high fever, blood in sputum, breathlessness | See a doctor; do not self-treat with the herb alone. | Authoritative guidance 12 |
Overdose, product quality and regulators
Summary. Animal toxicity data are limited but show no safety concern at the doses tested. Human data come from short trials.
Animal. Rats and dogs given up to 3,000 mg/kg of EPs 7630 by mouth showed no sign of liver damage in liver enzymes or bilirubin; human liver cell tests at up to 50 micrograms per ml for 24 hours showed no change in cell viability (Koch 2006, summarised in the EU report). Acute and 4-week rat and 13-week dog studies exist (Conrad 2007, as summarised).
Human doses studied. Trials ran 6 to 22 days, and one COPD trial 24 weeks. Specific amounts are left to a doctor or pharmacist.
High dose or long term signals. No long-term studies beyond the 24-week COPD trial. The EU report says genotoxicity and reproductive toxicity tests for the listed preparations are not available.
Overdose response. The EU report says no information on overdose is available.
Genotoxicity. The EU did not support a list entry because adequate published genotoxicity data are missing.
Toxic plant parts. The root is the part used. No toxic plant part was identified in the sources read; leaves are not used in the studied products.
No survey of pesticides, heavy metals or adulteration of Pelargonium sidoides products was found. P. sidoides and P. reniforme roots are sometimes both used, and wild plants are harvested, with local overharvesting reported.
Two species in one herbal name. EU assessment accepts both P. sidoides and P. reniforme roots; their coumarin profiles differ, and most clinical trials used one specific extract of P. sidoides (EPs 7630). 12 25
Wild harvest and overharvesting. Review says increasing demand has led to localised illegal harvesting of wild plants in southern Africa. 31
Different products. Products sold as 'pelargonium' may be root powder, other extracts, or combinations with honey, propolis, zinc or Coptis; trial results for EPs 7630 do not apply to them. Geranium oil comes from a different species (P. graveolens) and is a different product. 12
| Body | Action | Date |
|---|---|---|
| European Medicines Agency, Committee on Herbal Medicinal Products (HMPC) (European Union) | EU herbal monograph on Pelargonium sidoides DC / P. reniforme Curt., radix, revised 2024 (EMA/HMPC/765656/2022 assessment report; opinion EMA/HMPC/319732/2024). Traditional use only, for symptomatic treatment of the common cold, in adults and children from 3 years. Efficacy in acute bronchitis not accepted as well-established. Contraindication: hypersensitivity. Special precaution: liver toxicity and hepatitis reported, stop and see a doctor. Pregnancy and breastfeeding not recommended. Interactions: none reported. Adopted 23 of 27 votes; divergent positions from Finland, Ireland, Italy and the Netherlands. source | 2024-05-29 |
When to get medical help
- Yellow skin or eyes, dark urine, pale stools, severe tiredness, loss of appetite or upper right belly pain: stop the product and get medical help.
- Swelling of lips, tongue or face, hives, trouble breathing, fast heartbeat or fainting after a dose: emergency help.
- Nosebleeds or gum bleeding that does not stop, black stools or unusual bruising, especially if you take blood thinners.
- High fever, chest pain, shortness of breath, coughing blood or symptoms lasting more than about a week: see a doctor.
- Child under 3 with cough or fever: see a doctor.
Stop the supplement and contact a clinician or emergency service. In the US, Poison Control is 1-800-222-1222.
General information only, not medical advice. Ask a clinician or pharmacist before use, especially with medicines, in pregnancy or with a health condition. See the Natural Remedy Safety guide.
Frequently asked questions
Does Pelargonium sidoides work for bronchitis?
Probably a little, for symptoms, in people with a short chest infection. Several placebo-controlled trials found lower symptom scores with the EPs 7630 root extract after a week, and pooled analyses agree. But the Cochrane review rated the evidence low, the trials were short and mostly linked to the manufacturer, and EU regulators did not accept bronchitis benefit as proven. Bronchitis normally clears by itself. See a doctor if it is severe or lasts.
Does it help a common cold?
Maybe. Trials in adults found faster symptom relief, and a network analysis rated it moderate for colds. The Cochrane review rated the evidence very low. The EU accepts it only as a traditional herbal medicine for symptom relief of the common cold. Colds go away on their own, and antibiotics do not work on them.
Can Pelargonium damage the liver?
Reports of liver injury exist, including hepatitis, and one person in the early German reports needed a liver transplant. German regulators judged a link at least possible. Later re-assessments of earlier reports found none was clearly caused by the herb, because of other medicines, infections and gaps in the data. The EU kept a warning and monitored over 1,000 safety reports from 2013 to 2023, finding 9 serious liver or bile cases, and concluded benefit still outweighs risk. How often it happens is not known. Stop and see a doctor if you get yellow eyes or skin, dark urine or severe tiredness.
Is it safe with blood thinners like warfarin?
Not proven. The roots contain coumarins, so regulators checked. In rats the extract did not change clotting or warfarin's effect, and in two short human trials clotting tests were no different from placebo. But nosebleeds and gum bleeding are listed side effects, and nobody has studied people taking warfarin. Ask a doctor or pharmacist before using it if you take any blood thinner.
Can I use it during pregnancy or while breastfeeding?
It is not recommended. Safety in pregnancy and breastfeeding has not been established, and there is no data on fertility or on effects on the baby.
Is it safe for children?
The EU accepts traditional use for the common cold from age 3. A large open-label study of 591 children aged 1 to 5 found few side effects and no rise in liver enzymes over a week, but it had no placebo group and was funded by the manufacturer. Ireland, Italy and the Netherlands recorded objections about young children. Ask a pediatrician before giving it to a child.
Who paid for the studies?
Much of the research is linked to the maker of EPs 7630, Dr. Willmar Schwabe GmbH. The EU assessors note that the main placebo-controlled trials were done by the same investigators, mostly in Ukraine and Russia. Many pooled analyses have authors with company ties, and one large safety study was funded by the company. That does not make the results wrong, but it is why independent repeats matter.
What are the side effects?
Mild stomach upset (diarrhoea, stomach pain, nausea) is the most common. Rash, itching and swelling can happen, and rare severe allergic reactions have been reported. Nosebleeds, gum bleeding and liver problems are listed with unknown frequency. In a 300-person study, dizziness, drowsiness and headache each affected about 1 to 2 percent.
Does it help COPD or asthma?
Does it kill viruses or fight COVID-19?
Is this the same as geranium oil or garden geraniums?
Is it approved in the EU, US and elsewhere?
In the EU, it has a traditional-use herbal monograph (revised in 2024) for symptom relief of the common cold, in adults and children from 3 years. It is not accepted as well-established for bronchitis. We did not find a US FDA monograph, an NIH NCCIH page, a LiverTox entry or a LactMed entry for it.
Explore by health goal
Editorial transparency
- Written by
- AlternativeMed editorial team. Research compiled with AI assistance, then checked against PubMed records.
- Medical review
- None. This page has not been reviewed by a physician or pharmacist.
- First published
- 2026-10-25
- Last substantive update
- 2026-10-25
- How we research
- We searched PubMed and read the EU assessment report on Pelargonium root (EMA/HMPC/765656/2022, 2024) and the committee opinion in full, and recorded each study's design, people, product and result as reported. Only abstracts were read for most studies. Sources we could not find or open (NCCIH, LiverTox, LactMed, the FDA, the German Commission E text and the EU monograph annex itself) are marked not verified. Certainty ratings are the compiler's own reading unless a review gave its own. No study is cited that we could not verify.
- How we rate evidence
- See "How we rate evidence" in the Evidence tab.
- Independence
- No product is promoted on this page. No affiliate links are shown. If one is added later it will be labelled and kept apart from the evidence.
Sources 48
Each source was opened and checked. Where we read only the abstract, it says so. The small numbers in the text point here.
- Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis. Phytomedicine. 2008. PMID 18222667. DOI 10.1016/j.phymed.2007.11.023. (abstract)
- Alvero RGY, Balmadrid AS, Aquino RCC, et al.. Short-term Liver Safety of Pelargonium sidoides DC. Root (PELARGO) 20 mg Capsule: A Non-interventional Post-authorization Safety Study. Acta Med Philipp. 2026. PMID 41890334. DOI 10.47895/amp.vi0.12322. (abstract)
- Anheyer D, Cramer H, Lauche R, et al.. Herbal Medicine in Children With Respiratory Tract Infection: Systematic Review and Meta-Analysis. Acad Pediatr. 2018. PMID 28610802. DOI 10.1016/j.acap.2017.06.006. (abstract)
- Bachert C, Schapowal A, Funk P, et al.. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial. Rhinology. 2009. PMID 19382496. (abstract)
- Bereznoy VV, Riley DS, Wassmer G, et al.. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial. Altern Ther Health Med. 2003. PMID 14526713. (abstract)
- Brendler T, van Wyk BE. A historical, scientific and commercial perspective on the medicinal use of Pelargonium sidoides (Geraniaceae). J Ethnopharmacol. 2008. PMID 18725280. DOI 10.1016/j.jep.2008.07.037. (abstract)
- Büttner R, Schwermer M, Ostermann T, et al.. Complementary and alternative medicine in the (symptomatic) treatment of acute tonsillitis in children: A systematic review. Complement Ther Med. 2023. PMID 36868289. DOI 10.1016/j.ctim.2023.102940. (abstract)
- Chuchalin AG, Berman B, Lehmacher W. Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial. Explore (NY). 2005. PMID 16781588. DOI 10.1016/j.explore.2005.08.009. (abstract)
- Cinatl J Jr, Wass MN, Michaelis M. Multiple mechanisms enable broad-spectrum activity of the Pelargonium sidoides root extract EPs 7630 against acute respiratory tract infections. Front Pharmacol. 2024. PMID 39469622. DOI 10.3389/fphar.2024.1455870. (abstract)
- Conrad A, Frank U. Extract of Pelargonium sidoides (EPs 7630) displays anti-infective properties by enhanced phagocytosis and differential modulation of host-bacteria interactions. Planta Med. 2008. PMID 18240106. DOI 10.1055/s-2008-1034287. (abstract)
- Douros A, Bronder E, Andersohn F, et al.. Herb-Induced Liver Injury in the Berlin Case-Control Surveillance Study. Int J Mol Sci. 2016. PMID 26784183. DOI 10.3390/ijms17010114. (abstract)
- European Medicines Agency, HMPC (EMA/HMPC/765656/2022). Assessment report on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix (Final - Revision 2). European Medicines Agency. 2024. (full-text)
- European Medicines Agency, HMPC (EMA/HMPC/319732/2024). Opinion of the HMPC on a European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix (Revision 2). European Medicines Agency. 2024. (full-text)
- GBIF Secretariat. GBIF Backbone: Pelargonium sidoides DC.. GBIF. 2026. (full-text)
- GBIF Secretariat. GBIF Backbone: Pelargonium reniforme (Andrews) Curtis. GBIF. 2026. (full-text)
- Gökçe Ş, Dörtkardeşler BE, Yurtseven A, et al.. Effectiveness of Pelargonium sidoides in pediatric patients diagnosed with uncomplicated upper respiratory tract infection: a single-blind, randomized, placebo-controlled study. Eur J Pediatr. 2021. PMID 34304301. DOI 10.1007/s00431-021-04211-y. (abstract)
- Hoang MP, Seresirikachorn K, Chitsuthipakorn W, et al.. Herbal Medicines for Rhinosinusitis: A Systematic Review and Network Meta-analysis. Curr Allergy Asthma Rep. 2023. PMID 36609950. DOI 10.1007/s11882-022-01060-z. (abstract)
- Honchar O, Мykhailenko O, Holovchenko O, et al.. Pelargonium sidoides - from ethnopharmacology to evidence-based medicine: a systematic review. Phytomedicine. 2026. PMID 41653615. DOI 10.1016/j.phymed.2026.157880. (abstract)
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