Umckaloabo

Other Names

African geraniumAfrikanische GeranieBlack pelargoniumCortusina sidifolia Eckl. & Zeyh.GeranienGeranio SudafricanoGeraniospermum sidifolium KuntzeGéranium d'AfriqueGéranium d'Afrique du SudGéranium du CapGeranium rootGeranium sidifolium Thunb.i-Yeza lezikaliIcwayibaIkhubaloIkubaloIyeza lesikhaliKalwerbossieKap-PelargonieKapland-PelargonieKhoaara e NyenyaneKhoara-e-nyenyanePelargoniePelargonienPelargonii radixPelargonii sidoidis radixPelargonio SudafricanoPélargonium d'AfriquePélargonium du CapPelargonium reniforme CurtisPelargonium rootPelargonium sidaefoliumPelargonium sidoides DC.RabasRabassamRabassaminRacine de GéraniumRacine de PélargoniumSouth African geraniumSüdafrikanische PelargonieUmckaUmckaboUmckaloabaUvendle

Synopsis

Umckaloabo (Pelargonium sidoides DC.): A Comprehensive Reference

1. Identity

1.1 Botanical and Chemical Names

Pelargonium sidoides DC., also known as umckaloabo, is a member of the geranium family (Geraniaceae) and is native to South Africa. The genus name Pelargonium is derived from the Greek word Pelargos, meaning "stork," referring to the rostrum of the seed capsule, which resembles a stork's bill. The species epithet sidoides reflects the resemblance of the plant's foliage to the European plant Sida rhombifolia.

Both Pelargonium sidoides and the closely related Pelargonium reniforme have been used for the same purposes. The two species are very similar and have often been confused; gradual variation between them contributed to longstanding problems of taxonomic classification. The use of both species is accepted by the European Pharmacopoeia monograph.

Common names include: black pelargonium (English); kalwerbossie, rabassam (Afrikaans); ikubalo, iyeza lesikhali (Xhosa); khoara-e-nyenyane (Southern Sotho).

1.2 Etymology of "Umckaloabo"

The name "umckaloabo" is derived from two Zulu words: umkhuhlane, meaning "fever- and cough-related diseases," and uhlabo, meaning "chest pain."

1.3 Plant Description and Natural Source

Pelargonium sidoides forms a rosette-like plant with crowded leaves. It is very similar to some forms of P. reniforme, but is easily distinguished by its blackish rather than pink petals. The long-stalked leaves are mildly aromatic, heart-shaped, and velvety. It bears distinctive reddish-purple flowers, especially from late spring to summer. The plant has thick underground root-like branches, which have evolved to help it survive grass fires in its natural habitat.

Pelargonium sidoides is endemic to South Africa and Lesotho, and grows naturally in summer rainfall areas with average annual rainfall ranging from 200 to 800 mm per annum. Currently, P. sidoides is grown on specialized farms in South Africa using ecological cultivation methods.

1.4 Plant Part Used

The plant part used medicinally is the dried tuberous rhizome. Most of the raw material has historically been wild-crafted, though cultivated crop development has progressed significantly. The tuberous rhizomes are sliced and dried; rapid kiln drying yields a better quality product.

1.5 Pharmacopeial Recognition

The monograph of Pelargonium sidoides/reniforme root (Pelargonii radix) was introduced into the European Pharmacopoeia in 2008. Outside Europe, various liquid and solid preparations are available as herbal supplements, especially in North America and Mexico.

1.6 The Standardized Extract EPs® 7630

A special ethanolic extract of Pelargonium sidoides roots, EPs® 7630, is the active ingredient of the herbal medicinal product Umckaloabo® (ISO Arzneimittel, Ettlingen, Germany). EPs® 7630 is manufactured by Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany. The EMA's final EU herbal monograph specifies approved herbal preparations as: a liquid extract (DER 1:8–10), extraction solvent ethanol 11% (m/m); a dry extract (DER 4–25:1), extraction solvent ethanol 11% (m/m); or a dry extract (DER 4–7:1), extraction solvent ethanol 14% (V/V).

2. Traditional and Historical Use

2.1 Indigenous Southern African Use

Plant species indigenous to areas of South Africa are widely used by traditional healers of the Zulu, Basuto, Xhosa, and Mfengi tribes to treat dysentery, diarrhea, hepatic complaints, wounds, colds, fatigue, fevers, generalized weakness, and infections of the respiratory tract including tuberculosis.

Indigenous Zulu, Xhosa, and Basotho healers would prepare decoctions from the roots to address chest infections and digestive issues. Pelargonium sidoides has been used for centuries in South African traditional medicine for treating respiratory ailments (including coughs and tuberculosis) and gastrointestinal disorders like dysentery and diarrhoea.

The tuberous, woody roots of P. sidoides are traditionally used in the Eastern Cape Province of South Africa for their medicinal properties, particularly among the Xhosa people, who use infusions of the roots for the treatment of diarrhoea, dysentery, colds, and lung infections including tuberculosis.

The plant is also traditionally used by Zulu people to treat gonorrhoea, diarrhoea, and dysentery. In South Africa, polyphenol-rich herbal preparations made from roots of Pelargonium sidoides and Pelargonium reniforme are traditionally used to treat respiratory and gastrointestinal infections, dysmenorrhea, and hepatic disorders.

These plants, often referred to by their original Khoi-Khoi name rabas, were among the first to be recorded by early travellers such as van der Stel (1685) and Thunberg (1773). Of the 35 indigenous medicinal plants that have been accurately recorded at the Cape in the period 1650–1800, no fewer than six are species of Pelargonium. Although the indigenous knowledge about this plant has not yet been thoroughly recorded, it is believed that knowledge has been in existence for a long time.

2.2 Charles Henry Stevens and the Introduction to Europe

The plant's introduction to Western medicine dates to 1897, when Englishman Charles Henry Stevens, suffering from tuberculosis, travelled to South Africa and was treated by a local healer with a potion made from P. sidoides root. After recovering, Stevens brought the remedy to Europe as "Stevens' Cure," also known by the African name Umckaloabo, promoting it as a tuberculosis treatment.

Upon his return to England, Stevens imported the medicine's raw ingredients from South Africa and began to produce a remedy called Stevens' Consumption Cure. This product also went by the name of Umckaloabo. Word of the cure spread, and subsequently Umckaloabo was tested and its healing properties investigated by Dr. Sechehaye of the University of Geneva in the mid-1920s. After a tentative initial clinical trial, Dr. Sechehaye went on to successfully prescribe the remedy to 800 tuberculosis patients between 1920 and 1929. By the standards of the day, the clinical results were particularly well documented and included 64 detailed case studies.

Stevens' Cure (Umckaloabo) emerged as a patent medicine claiming to treat tuberculosis in the United Kingdom at the beginning of the 20th century. However, due to its identity being shrouded in secrecy, it was never truly accepted by the medical community. It was "rediscovered" in the 1970s and subsequently developed into a very popular and successful phytopharmaceutical for the treatment of upper respiratory tract infections.

A 2024 study used UPLC-MS analysis to compare historical Stevens' Cure samples with modern Pelargonium root preparations. The authors confirmed that the ingredient — P. sidoides DC. — is indeed the same as used in modern phytotherapy, and they attribute the first ethnopharmacological record of P. sidoides being used for the treatment of tuberculosis to C. H. Stevens, the "creator" of Umckaloabo.

2.3 Modern Commercial Development

Extracts of the root have been available without prescription in German pharmacies since 1983 and have been widely used to treat infections of the sinus, throat, and respiratory tract. Umckaloabo received full market authorization by the German drug regulatory agency in 2005. Until this time, a tincture 1+10 from P. sidoides/reniforme was used; from 2005, the ingredients changed to a solution of P. sidoides.

EPs® 7630-containing products have since been approved in a number of countries in Europe, Asia, Australia, Central America, and South America for indications including acute bronchitis, common colds, acute respiratory tract infections, acute rhinosinusitis, and acute tonsillopharyngitis.

3. Key Constituents and Active Compounds

3.1 Overview of the Phytochemical Profile

A broad range of constituents have been identified in EPs® 7630 and other Pelargonium sidoides extracts, including members of different compound classes such as amino acids, phenolic acids, α-hydroxy-acids, vitamins, polyphenols, flavonoids, coumarins, coumarin glucosides, coumarin sulphates, nucleotides, monomeric and oligomeric carbohydrates, minerals, peptides, purine derivatives, and highly substituted benzopyranones.

3.2 Principal Constituents

Polymeric polyphenols and coumarins have been identified as the principal ingredients of EPs® 7630.

Polyphenols / Proanthocyanidins: The main constituents of EPs® 7630 include coumarins (e.g., umckalin) and flavanols (polyphenols). The latter comprise oligomeric proanthocyanidins, which are highly abundant (approximately 40%) in EPs® 7630, especially oligo- and polymeric prodelphinidins. These are constructed mainly of gallocatechin and epigallocatechin components, present with different interflavonoid bonds in Pelargonium sidoides roots.
Coumarins (Benzopyranones): Umckalin and umckalin sulfate are characteristic representatives of benzopyranones (coumarins) found in EPs® 7630. Taxifolin sulfate and other flavonoid sulfates were recently discovered as genuine constituents in P. sidoides root extract EPs® 7630. Umckalin (chemically: 7-Hydroxy-5,6-dimethoxy-2H-1-benzopyran-2-one) and umckalin sulfate (5,6-Dimethoxy-7-(sulfooxy)-2H-1-benzopyran-2-one) have been isolated and characterized.
Additional coumarins: Characterized constituents also include highly oxygenated coumarins such as 7-hydroxy-5,6-dimethoxycoumarin and 6,8-dihydroxy-5,7-dimethoxycoumarin, as well as gallic acid-derivatives.
Catechins: Catechins such as gallocatechin, epigallocatechin, and epigallocatechin gallate have been identified in EPs® 7630.
Other phenolics: Other constituents include polymeric proanthocyanidins, monomeric flavan-3-ols, phenolic acids, and gallic acid, as well as small amounts of quercetin and sitosterol-glucoside.
Purine derivatives: Three distinct purine derivatives, probably intermediates of DNA synthesis, have been identified by phytochemical means. Taken together, the major identified constituents amount to approximately 60 to 70% of the total weight of EPs® 7630.

3.3 Note on Anticoagulant Potential

The 7-hydroxycoumarin derivatives found in EPs® 7630 (including umckalin) differ in chemical structure from the known anticoagulant coumarins and are not associated with anticoagulant activity or interaction with warfarin and its pharmacokinetics. Moreover, the coumarins so far identified in EPs® 7630 do not possess the structural characteristics needed for anticoagulant activity.

4. Established and Proposed Mechanisms of Action

4.1 Overview

The mechanisms of EPs® 7630 include antibacterial, antiviral, immunomodulatory, tissue-protective, and secretolytic/secretomotoric activity, as well as enhancing epithelial barrier integrity. Given the broad range of clinical activities and documented pharmacological effects, it is likely that multiple mechanisms, which are at least in part exerted by different constituents of the extract, may contribute to the observed therapeutic profile. There is a limited understanding of which active ingredients are responsible for which specific effects.

4.2 Antiviral Mechanisms

EPs® 7630 inhibits virus replication by the inhibition of virus release, by the inhibition of virus attachment and entry, by inducing an interferon response, and by additional mechanisms that will need to be elucidated by future research.

In vitro, EPs® 7630 shows efficacy against cellular infections with influenza virus, HSV, EMCV, RSV, coronavirus, parainfluenza virus, and coxsackie virus, and this appears to be mainly mediated indirectly by inhibition of virus attachment and spreading.

Distinct antiviral effects of EPs® 7630 have been observed in concentrations up to 100 μg/ml, with activity reported mainly against enveloped viruses such as influenza A virus (H1N1, H3N2), respiratory syncytial virus (RSV), parainfluenza virus, and human coronavirus HCoV-229E. Impaired viral hemagglutination and reduced neuraminidase activity might inhibit influenza A virus entry and release of viral particles. Although the distinct contributions of individual constituents are still not fully defined, polyphenolic compounds — in particular prodelphinidins — may be responsible for the described antiviral effects.

4.3 Immunomodulatory Mechanisms

EPs® 7630 has antibacterial and antiviral effects that are mediated partly via stimulation of host defense mechanisms such as release of tumor necrosis factor alpha and nitric oxide, the stimulation of interferon-β, and an increase in natural killer cell activity.

Several in vitro studies conducted with EPs® 7630 showed an inhibitory effect (growth inhibition) against several bacterial strains (Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, and Staphylococcus aureus, especially multi-resistant strains). This effect is brought about by an immune modulation mechanism mediated by the activation of macrophages (with the involvement of cytokine interferon-gamma) and the consequent increase in the production of nitric oxide. The activated macrophages produce, in turn, different cytokines, such as interleukin (IL)-1, IL-2, and tumor necrosis factor-alpha.

Activation of the MAP kinase pathway and subsequent regulation of different cytokines such as tumor necrosis factor α, interferon-β, or interleukin-22 have been described, depending on the experimental context.

4.4 Antibacterial Mechanisms

EPs® 7630 inhibits the adherence of bacteria such as Streptococcus pyogenes and Helicobacter pylori to epithelial cells in vitro. Using fluorescent-labelled group A-streptococci and viable human laryngeal cells (HEp-2) as a model, flow cytometric measurements showed prominent (by up to approximately 45% compared with untreated cells) anti-adhesive and anti-invasive capabilities of EPs® 7630 in a concentration-dependent manner (<30 μg/mL).

Ciliated cells isolated from the nasal epithelium enhanced their ciliary beat frequency in the presence of EPs® 7630, which should allow a better removal of excess mucus and bacteria.

4.5 Roles of Specific Constituent Classes

Proanthocyanidins have been shown to contribute to the antibacterial, antiviral, and immunomodulatory activities of Pelargonium sidoides extracts. Research testing Pelargonium sidoides root extract against Mycobacterium smegmatis identified scopoletin, umckalin, catechin, and epigallocatechin as active ingredients.

4.6 Secretolytic and Epithelial Effects

In an animal study, antitussive, secretolytic, and anti-inflammatory effects of EPs® 7630 were detected following oral administration at human-equivalent doses. Moreover, EPs® 7630 interferes with the replication of respiratory viruses and reduces rhinovirus infection to human bronchial cells.

The combination of antiviral and immunomodulatory effects may enable EPs® 7630 to tackle acute viral respiratory infections both in early stages of the disease process (driven by virus replication) and in later stages (caused by an overshooting immune response). Hence, EPs® 7630 has been described as a prime example of a plant extract with evidence-based clinical efficacy, including a solid understanding of the underlying mechanisms of action.

5. Scientific Evidence by Area of Use

5.1 Acute Bronchitis in Adults

In Germany, EPs® 7630 is approved for the therapeutic use in patients with acute bronchitis.

A systematic review and meta-analysis (Agbabiaka et al., 2008) identified six RCTs meeting inclusion criteria, of which four were suitable for statistical pooling. Methodological quality of most trials was good. One study compared EPs® 7630 against conventional non-antibiotic treatment (acetylcysteine); the other five studies tested EPs® 7630 against placebo. All RCTs reported findings suggesting the effectiveness of P. sidoides in treating acute bronchitis. Meta-analysis of the four placebo-controlled RCTs suggested that EPs® 7630 significantly reduced bronchitis symptom scores in patients with acute bronchitis by day 7. No serious adverse events were reported. The authors concluded there is encouraging evidence that P. sidoides is effective compared to placebo for patients with acute bronchitis.

The 2013 Cochrane systematic review (Timmer et al.) covered three trials (746 patients) of efficacy in acute bronchitis in adults that showed substantial heterogeneity for all relevant outcomes, and three trials (819 children) that were similarly inconsistent for acute bronchitis in children. The study quality was rated as moderate for all studies (due to unvalidated outcome assessment, minor attrition problems, and investigator-initiated trials only), and based on funnel plot analysis there was suspicion of publication bias.

In adults, symptoms were consistently improved after seven days, with an effect observed on individual scale items after four days. In a review of the Bronchitis Severity Score (BSS) including 17 studies of Pelargonium sidoides (11 adult and 8 children studies), a difference in BSS was seen by day 3–5.

A meta-analysis of eight double-blind, randomized, placebo-controlled, manufacturer-funded trials (N=746) of low to very low quality revealed effectiveness of P. sidoides (EPs® 7630) alcoholic extract for relieving acute bronchitis symptoms in adults and children, and possibly sinusitis in adults as well. Very weak evidence supported effectiveness for symptom relief of acute rhinosinusitis and the common cold in adults.

Evidence characterization: Several clinical trials and a Cochrane review have concluded that Pelargonium sidoides root extract may be effective at relieving symptoms of acute bronchitis in both adults and children, but the overall quality of the evidence was considered low. Most trials are manufacturer-funded, which is a relevant limitation noted by independent reviewers. It should be noted that the majority of included trials were manufacturer-funded, as was the lead author of the systematic review.

5.2 Acute Bronchitis in Children and Adolescents

For acute bronchitis in children, three studies showed inconsistent but overall positive combined effect.

Eight RCTs investigating the application of EPs® 7630 in acute bronchitis, acute tonsillopharyngitis, and acute respiratory tract infections in the context of chronic preconditions were identified. Results showed a statistically significant improvement of acute respiratory tract infection symptom severity for EPs® 7630 as compared to controls.

In children/adolescents with acute bronchitis, 79.6% of participants treated with EPs® 7630 and 41% treated with placebo showed a reduction in the intensity of cough by at least 50% of baseline values at day 7.

Eight randomized, double-blind, placebo-controlled trials involving 1,253 children and adolescents demonstrated the safety and efficacy of EPs® 7630 for the treatment of acute respiratory tract infections. A meta-analysis conducted with five randomized controlled trials comprising a total of 990 patients revealed further evidence for efficacy and safety in the treatment of respiratory tract infections in children and adolescents.

A systematic review on herbal treatments in children identified EPs® 7630 as the most commonly investigated one. Moreover, a systematic overview with subgroup-analyses of clinical trial data for children younger than 6 years provided evidence of the effectiveness and safety of EPs® 7630 in this age group.

Evidence characterization: The overall quality of the evidence was considered low for main outcomes in acute bronchitis in children and adults, and very low for acute sinusitis. Positive results are consistent but heterogeneous, and most trials were industry-funded.

5.3 Acute Rhinosinusitis

EPs® 7630 was shown to be effective in clinical trials with patients suffering from tonsillopharyngitis, rhinosinusitis, common cold, or COPD. P. sidoides may be effective in alleviating symptoms of acute rhinosinusitis and the common cold in adults, but doubt exists. It may be effective in relieving symptoms in acute bronchitis in adults and children, and sinusitis in adults.

Evidence characterization: Evidence for acute rhinosinusitis is of very low quality, based on a small number of trials. The Cochrane review specifically noted that doubt exists regarding efficacy for sinusitis.

5.4 Acute Tonsillopharyngitis

After positive clinical study results in children with acute bronchitis, a double-blind placebo-controlled clinical trial with a group sequential design investigated the efficacy and tolerability of EPs® 7630 in 6- to 10-year-old patients with acute tonsillopharyngitis who showed no evidence of group A β-hemolytic streptococcus. Treatment duration was 6 days. The primary efficacy variable was change in the sum score of the tonsillitis severity score (TSS) on day 4 compared to baseline.

Evidence characterization: Evidence for tonsillopharyngitis is preliminary and mostly limited to non-streptococcal cases in children. Further well-powered independent trials are needed.

5.5 Common Cold in Adults

P. sidoides may be effective in alleviating symptoms of acute rhinosinusitis and the common cold in adults, but doubt exists. A meta-analysis covering five trials in adults with common cold found that EPs® 7630 reduced cough intensity, though data from 2,195 participants from 11 trials (3 in children/adolescents with acute bronchitis, 3 in adults with acute bronchitis, 5 in adults with common cold) were eligible for analysis.

Evidence characterization: Evidence for the common cold is considered very low quality by the Cochrane review. Positive trends are noted but not sufficiently replicated to permit strong conclusions.

5.6 COPD (Chronic Obstructive Pulmonary Disease)

A randomized, double-blind, placebo-controlled trial of EPs® 7630 in adults with COPD was conducted (Matthys et al., 2013). EPs® 7630 was shown to be effective in clinical trials with patients suffering from COPD. Clinical evidence demonstrates that EPs® 7630 is a safe and effective treatment for a range of acute infectious respiratory illnesses and that it can also improve conditions like COPD and asthma.

Evidence characterization: Evidence for COPD remains limited to a small number of trials. The results are encouraging but require independent replication before firm conclusions can be drawn.

5.7 SARS-CoV-2 and Emerging Viral Pathogens

A preclinical study assessed whether EPs® 7630 affects SARS-CoV-2 propagation and the innate immune response in the human lung cell line Calu-3. In direct comparison to other highly pathogenic coronaviruses (SARS-CoV, MERS-CoV), SARS-CoV-2 growth was most efficiently inhibited at a non-toxic concentration, with an IC50 of 1.61 μg/ml. The cellular entry step of SARS-CoV-2 was significantly reduced by EPs® 7630 pretreatment (10–100 μg/ml).

Evidence characterization: All SARS-CoV-2 data are in vitro and/or animal studies only. No clinical trials in COVID-19 patients have been reported in the reviewed sources. These findings are hypothesis-generating and cannot be extrapolated to clinical benefit.

5.8 Tuberculosis

Pelargonium sidoides is an important traditional medicine in South Africa with a well-defined history of both traditional and documented use. There is also historical evidence of use in the treatment of tuberculosis. However, modern clinical evidence for anti-tuberculosis efficacy is not established. The aim of more recent basic science work has been to develop a platform of Mycobacterium tuberculosis (Mtb) kinase enzymes that may be used for the identification of therapeutically relevant ethnobotanical extracts and to allow drug target identification.

Evidence characterization: Traditional use for tuberculosis is well-documented, but contemporary clinical evidence is absent. Current research is limited to early-stage preclinical investigations.

5.9 Antibiotic Stewardship Context

There is clinical evidence showing that EPs® 7630 is a safe and effective treatment for a range of acute infectious respiratory illnesses. Moreover, EPs® 7630 has been shown to reduce the use of antibiotics, which is important in the context of rising antibiotic resistance levels. As an alternative to antibiotic treatments, EPs® 7630 has the advantage of not promoting microbial resistances. The latter aspect is mainly explained by its characteristic not to interfere with the metabolism of viruses or bacteria, acting primarily through host defense mechanisms.

6. Dosage Forms and Reported Dosages

Umckaloabo is available in both tablet and liquid forms.

Formulations studied in trials include tablets (10 to 30 mg three times daily for 7 days) and alcohol-extract liquid preparations (3 × 10 to 60 drops for 7 to 30 days).

For liquid EPs® 7630 preparations, the dose stratification by age reported in clinical trials is: 3 × 10 drops for children aged between 1–5 years; 3 × 20 drops for children aged between 6–12 years; and 3 × 30 drops for adults and adolescents over the age of 12 years.

Today herbal medicines containing pelargonium are found in tablets, tinctures, and syrups. The Cochrane review suggested that the liquid formulation may be more effective than the tablets, although the number of trials was limited.

7. Body Systems and Health Areas Associated with Umckaloabo

Respiratory system: Acute bronchitis, common cold, acute rhinosinusitis, acute tonsillopharyngitis, COPD exacerbations. These are the primary evidence-supported applications. The ESCOP monograph covers respiratory tract infections, common colds, sore throat, and cough.
Immune system: Immunomodulation via macrophage activation, natural killer cell stimulation, cytokine modulation (TNF-α, IL-1, IL-2, interferon-β), and enhancement of phagocyte oxidative burst.
Gastrointestinal system: For centuries, the roots have been used in traditional South African medicine for the treatment of respiratory diseases, diarrhea, dysmenorrhea, and liver disorders. These remain exclusively traditional-use indications; there are no modern clinical trial data in these areas from the reviewed sources.
Antimicrobial (indirect): Via inhibition of bacterial adhesion to epithelial cells and enhancement of mucociliary clearance.

8. Safety Considerations and Drug Interactions

8.1 General Tolerability

A comprehensive review on safety and tolerability data from 29 clinical trials and non-interventional studies including a total of 10,026 patients showed EPs® 7630 to be well tolerated in both children and adults.

In safety studies in young children, the number of adverse events was similarly low in both treatment groups and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) and gastrointestinal disorders (syrup: 2.7%; solution: 3.2%).

8.2 Common Adverse Events

Potential adverse reactions related to EPs® 7630 use include mild gastrointestinal (GI) side effects (diarrhea, epigastric discomfort, nausea or vomiting, dysphagia), mild nasal and gingival bleeding, and allergic reactions. Adverse events were more common with P. sidoides than placebo, but none were serious.

8.3 Hepatotoxicity Concern and Resolution

Although previous spontaneous reports raised suspicion about this herbal medicine and possible hepatotoxicity, subsequent publications stated that hepatotoxicity was not related to P. sidoides. Many other reports have also highlighted the safety and tolerability of this herbal medicine, both in children and adults. Investigators concluded that there is currently no evidence of hepatotoxicity related to the use of Pelargonium.

The EMA assessment documents corroborate this: Koch (2006) examined the hepatotoxic effect of extracts from the roots of Pelargonium sidoides. Studies on rats and dogs involving the oral administration of up to 3000 mg/kg EPs® 7630 provided no evidence of liver-damaging effects. There were no effects on plasma transaminase, lactate-dehydrogenase and alkaline phosphatase activities, and the level of bilirubin. These positive results were backed up by in vitro tests on human hepatocytes and hepatoma cells. Nevertheless, the warning of hepatitis when taking Pelargonium remains on the Summary of Product Characteristics (SmPC) and information leaflet of the licensed products.

8.4 Interaction with Anticoagulants

In view of the coumarin content of EPs® 7630, it has been suggested that the administration of Umckaloabo could possibly be associated with an increased risk of bleeding. Studies were conducted to investigate whether a change in blood coagulation parameters or an interaction with coumarin-type anticoagulants occurred after administration of EPs® 7630 to rats. No effect on partial thromboplastin time or thrombin time was observed after oral administration of EPs® 7630 (10, 75, 500 mg/kg) for 2 weeks, while treatment with warfarin (0.05 mg/kg) for the same period resulted in significant changes in blood coagulation parameters. When EPs® 7630 (500 mg/kg) and warfarin (0.05 mg/kg) were given concomitantly, the anticoagulant action of warfarin was not influenced; the pharmacokinetics of warfarin was also unchanged.

8.5 Interaction with Penicillin

A placebo-controlled, randomized, double-blind clinical trial in healthy volunteers demonstrated a lack of pharmacological interaction between EPs® 7630 and penicillin.

8.6 Sustainability and Harvesting Concerns

The growing international demand for Pelargonium sidoides root extract has led to an increase in the number of gatherers as well as the volume of harvested plant materials. Most of the raw material has historically been wild-crafted, but crop development has progressed to a point where significant quantities of raw material are now being produced from cultivated plants. This shift toward cultivation is significant from both a supply-chain and conservation perspective.

References

Health Conditions

Health conditions that Umckaloabo may help support.

Viral Immune ResponseScientific
Umckaloabo is the traditional South African name for Pelargonium sidoides extract (EPs 7630) with multiple RCTs confirming efficacy for acute bronchitis and viral respiratory infections. German Commission E-approved pharmaceutical for acute bronchitis; direct antiviral and immunostimulatory mechanisms are well-characterized.

Body Systems

Body systems that Umckaloabo may help support.

No body systems available.