Pelargonium sidoides

BACKGROUND: Acute bronchitis is the most common respiratory disease. Mixture of Ivy Leaf Extract and Coptidis rhizome syrup has shown good treatment efficacy against chronic bronchitis and acute respiratory infections. This study aimed to evaluate the efficacy and safety of Mixture of Ivy Leaf Extract and Coptidis rhizome compared with those of Pelargonium sidoides extract, for the treatment of acute bronchitis. METHODS: We performed a multicenter, randomized, double-blind, active-controlled, parallel phase III study in 220 patients with acute bronchitis. The participants were offered either Mixture of Ivy Leaf Extract and Coptidis rhizome syrup (AGS) and placebo of P. sidoides tablet or placebo syrup and active tablet of P. sidoides (AGU) for 7 days. The primary endpoint was the change in the Bronchitis Severity Score (BSS) from the baseline visit (visit 2) to day 7 (visit 3). RESULTS: For the primary outcome, there was no significant difference in the change of total BSS between visits 2 and 3 (-4.10 ± 1.93 vs. -4.24 ± 1.85, p = 0.5125), and since the upper limit of the confidence interval (1.00) was smaller than the predetermined non-inferiority margin (1.17), it was confirmed that the AGS group was non-inferior to the AGU group. The changes in each symptom in the BSS between visits 2 and 3 also showed no significant differences. The overall improvement rate measured by the investigator (91.7 vs. 89.7%; p = 0.3506) and the satisfaction rate of the participants at visit 3 also showed no significant differences (97.2 vs. 94.4%; p = 0.4388). Regarding safety issues, adverse reactions were noted in both groups similarly, with no serious adverse events (4.55 vs. 3.64%, p > 0.999). CONCLUSION: Mixture of Ivy Leaf Extract and Coptidis rhizome syrup is as effective and safe as P. sidoides in controlling symptoms of acute bronchitis.

BACKGROUND/AIMS: DW1601, an oral fixed dose combination syrup composed of DW16011 and Pelargonium sidoides, was developed to enhance the symptom relief effect in patients with acute bronchitis. We evaluated the efficacy and safety of DW1601 compared to DW16011 or P. sidoides for treatment of acute bronchitis using a randomized, double-blind, placebocontrolled, multi-centre trial design. METHODS: A total of 204 patients with acute bronchitis was randomized 1:1:1 to receive DW1601 (n = 67), DW16011 (n = 70), or P. sidoides (n = 64) for 7 days. The primary outcome was efficacy of DW1601 compared to DW16011 or P. sidoides in reducing the total bronchitis severity score (BSS) at day 4 of treatment. Secondary endpoints were changes in total and symptomspecific BSS, response rate and patient satisfaction rate. Safety analysis was assessed at day 7. RESULTS: At 4 days after medication, decrease of total BSS from baseline was significantly greater in the DW1601 group than in the DW16011 group (-3.51 ± 0.18 vs. -2.65 ± 0.18, p = 0.001) or P. sidoides group (-3.56 ± 0.18 vs. -2.64 ± 0.19, p < 0.001). In addition, the BSS total score at day 7 and the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or P. sidoides group. Participants treated with DW1601 showed higher rates of response and satisfaction than control groups (response rate, DW1601, 100% vs. DW16011, 85.7% vs. P. sidoides, 85.9%; satisfaction rate, DW1601, 92.6% vs. DW16011, 82.9% vs. P. sidoides, 81.2%). Significant adverse events were not observed in the DW1601 group. CONCLUSION: DW1601 is superior to DW16011 or P. sidoides in improving symptoms of acute bronchitis.

Upper respiratory tract infections (URTIs) are a condition characterized by upper airway inflammation often caused by viruses in humans. The present study aimed to assess the effectiveness of the liquid herbal drug preparation from the root extracts of Pelargonium sidoides in improving symptoms of uncomplicated URTIs. One hundred sixty-four patients with URTI were randomized and given either verum containing the root extracts of Pelargonium sidoides (n = 82) or a matching placebo (n = 82) in a single-blind manner for 7 days. The median total scores of all symptoms (TSS) showed a significant decreasing trend in the group treated with the root extracts derived from Pelargonium sidoides compared to the placebo group from day 0 to day 7 (TSS significantly decreased by 0.85 points in the root extract group compared to a decrease of 0.62 points, p = 0.018). "Cough frequency" showed a significant improvement from day 0 to day 3 (p = 0.023). There was also detected a significant recovery in "sneezing" on day 3 via Brunner-Langer model, and it was detected that the extract administration given in the first 24 h onset of the symptoms had provided a significant improvement in day 0 to day 3 (difference of TSS 0.18 point, p = 0.011).Conclusion: The findings of the study revealed that the Pelargonium sidoides extracts are effective in relieving the symptom burden in the duration of the disease. It may be regarded as an alternative option for the management of URTIs. What is Known: • Upper respiratory tract infections (URTIs), an inflammation on the upper airways, are the most common infectious disease in children. • Pelargonium sidoides, a traditional medicinal plant native to South Africa, is one of the ornamental geraniums that is thought to be effective in treating URTIs What is New: • It may be revealed that the dried root extract of Pelargonium sidoides compared with placebo might be an alternative treatment in improving the symptoms such as dry cough, sneezing, and relieving cough frequency. • The administration of the root extract at the onset of URTIs' signs may be regarded as an adjunctive option for the management of URTIs due to its effectiveness in decreasing the

Neuraminidaseis a key enzyme in the life cycle of influenza viruses and is present in some bacterial pathogens. We here assess the inhibitory potency of plant tannins versus clinically used inhibitors on both a viral and a bacterial model neuraminidase by applying the 2'-(4-methylumbelliferyl)-α-d-N-acetylneuraminic acid (MUNANA)-based activity assay. A range of flavan-3-ols, ellagitannins and chemically defined proanthocyanidin fractions was evaluated in comparison to oseltamivir carboxylate and zanamivir for their inhibitory activities against viral influenza A (H1N1) and bacterial Vibrio cholerae neuraminidase (VCNA). Compared to the positive controls, all tested polyphenols displayed a weak inhibition of the viral enzyme but similar or even higher potency on the bacterial neuraminidase. Structure-activity relationship analyses revealed the presence of galloyl groups and the hydroxylation pattern of the flavan skeleton to be crucial for inhibitory activity. The combination of zanamivir and EPs® 7630 (root extract of Pelargonium sidoides) showed synergistic inhibitory effects on the bacterial neuraminidase. Co-crystal structures of VCNA with oseltamivir carboxylate and zanamivir provided insight into bacterial versus viral enzyme-inhibitor interactions. The current data clearly indicate that inhibitor potency strongly depends on the biological origin of the enzyme and that results are not readily transferable. The therapeutic relevance of our findings is briefly discussed.

BACKGROUND: Spontaneous reports of herb induced liver injury (HILI) represent a major regulatory issue, and it is in the interest of pharmacovigilance to identify and quantify previously unrecognized adverse reactions and to confirm or refute false positive signals of safety concerns. In a total of 13 spontaneous cases, liver disease has initially been attributed to the use of Pelargonium sidoides (PS), a plant from the South African region. Water/ethanol extracts derived from its roots are available as registered herbal drugs for the treatment of upper respiratory tract infections including acute bronchitis. OBJECTIVES: The present study examines whether and to what extent treatment by PS was associated with the risk of liver injury in these spontaneous cases. STUDY DESIGN: Overall, 13 spontaneous cases with primarily suspected PS hepatotoxicity were included in the study. Their data were submitted to a thorough clinical evaluation that included the use of the original and updated scale of CIOMS (Council for International Organizations of Medical Sciences) to assess causality levels. These scales are liver specific, validated for liver toxicity, structured and quantitative. RESULTS: None of the 13 spontaneous cases of liver disease generated a positive signal of safety concern, since causality for PS could not be established on the basis of the applied CIOMS scales in any of the assessed patients. Confounding variables included comedication with synthetic drugs, major comorbidities, low data quality, lack of appropriate consideration of differential diagnoses, and multiple alternative diagnoses. Among these were liver injury due to comedication, acute pancreatitis and cholangitis, acute cholecystitis, hepatic involvement following lung contusion, hepatitis in the course of virus and bacterial infections, ANA positive autoimmune hepatitis, and other preexisting liver diseases. In the course of the case assessments and under pharmacovigilance aspects, data and interpretation deficits became evident. Possible improvements include appropriate data quality of cases in spontaneous reports, case assessment by skilled specialists, use of a validated liver specific caus

137. J Pharm Belg. 2010 Dec;(4):135-6. [Pelargonium sidoides - oral (Kaloban).]. [Article in French] [No authors listed]

7. Phytomedicine. 2007;14 Suppl 6:40-5. doi: 10.1016/j.phymed.2006.11.026. Epub 2006 Dec 22. Treatment of rats with the Pelargonium sidoides extract EPs 7630 has no effect on blood coagulation parameters or on the pharmacokinetics of warfarin. Koch E(1), Biber A. Author information: (1)Preclini

OBJECTIVES: To elucidate the benefits, pitfalls and risks of phytotherapy in the clinical practice of otorhinolaryngology. MATERIAL AND METHODS: The PubMed and Cochrane databases were searched using the following keywords: phytotherapy, phytomedicine, herbs, otology, rhinology, laryngology, otitis, rhinitis, laryngitis and otorhinolaryngology. Seventy-two articles (18 prospective randomized studies, 4 Cochrane analyses, 4 meta-analysis and 15 reviews of the literature) devoted to clinical studies were analyzed. Articles devoted to in vitro or animal studies, biochemical analyses or case reports (including fewer than 10 patients) and articles dealing with honey, aromatherapy or minerals were excluded. RESULTS: Per os ginkgo biloba has no indications in tinnitus, presbycusis or anosmia following viral rhinitis. Traditional Asian medicine has no proven benefit in sudden deafness or laryngeal papillomatosis. Per os mistletoe extracts associated to conventional treatment for head and neck squamous cell carcinoma does not increase 5-year survival. Extracts of various herbs, notably echinacea, eucalyptus, petasites hybridus, pelargonium sidoides, rosemary, spirulina and thyme, show superiority over placebo for rhinosinusitis and allergic rhinitis, as does gingko biloba for selected vertigo. There have been encouraging preliminary results for intratumoral injection of mistletoe in head and neck carcinoma and acupoint herbal patching for allergic rhinitis. Herb intake should be screened for in case of certain unexplained symptoms such as epistaxis, headache or dizziness, or signs suggesting allergy. Phytotherapy should be interrupted ahead of surgery and/or chemotherapy. CONCLUSION: Scientific proof of the benefit of phytotherapy in otorhinolaryngology remains to be established but, given its widespread use and the reported data, knowledge of this form of treatment needs to be developed.

BACKGROUND: Pelargonium sidoides DC. (Geraniaceae) has a long history of traditional use among indigenous peoples of Southern Africa for treating respiratory and gastrointestinal disorders. Its transformation into the modern pharmaceutical product Umckaloabo (EPs® 7630) exemplifies the transition from traditional medicine to evidence-based therapeutics. PURPOSE: To provide a systematic analysis of P. sidoides, spanning from its botanical characteristics and ethnobotanical roots to its development as a regulated phytomedicine. The review focuses on the plant's unique phytochemical profile and provides a detailed synthesis of its molecular and systems-biological mechanisms of action, cultivation sustainability, and clinical efficacy in managing respiratory tract infections. STUDY DESIGN AND METHODS: A systematic search was conducted across PubMed, Scopus, and Cochrane Library up to December 2025 following PRISMA guidelines. Sources included scientific articles, pharmacopoeias, patents, and ethnobotanical records in English and Ukrainian. RESULTS: The systematic synthesis of identified records characterizes the chemical diversity of P. sidoides, focusing on specialized metabolites such as highly substituted benzopyranones, prodelphinidins, and unique coumarin sulfates. The review discusses modern cultivation practices, sustainability issues, and comparative extraction techniques, while analytical methods such as HPLC, LC-MS, and TLC for standardization are summarized. The pharmacological profile is defined by multi-target activity, encompassing immunomodulatory, antibacterial, and antiviral effects, including studies on SARS-CoV-2 and other respiratory pathogens. Analysis of available clinical data validates the therapeutic use of P. sidoides root preparations for managing acute bronchitis, rhinosinusitis, and tonsillopharyngitis. CONCLUSION: This study demonstrates that the integration of P. sidoides into modern healthcare is supported by the synergy between traditional knowledge and molecular and clinical validation. By mapping the developmental trajectory - from wild harvesting to systems-biological evidence - this review identifies P. sidoides as a model for th

PURPOSE OF REVIEW: To analyze and compare the effects of herbal medicines (HMs) for treating different forms of rhinosinusitis. RECENT FINDINGS: Forty-seven randomized controlled trials evaluating 18 HMs in six different rhinosinusitis populations were included in the network meta-analysis. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. For the common cold, Pelargonium sidoides offered the most beneficial effect on symptom improvement (moderate certainty of evidence). For acute post-viral rhinosinusitis, Cineole and Pelargonium sidoides were the most effective treatments for controlling symptoms (moderate certainty), while Spicae aetheroleum was most effective for health-related quality of life (HRQoL) improvement (moderate certainty). For chronic rhinosinusitis without nasal polyps (CRSsNP), Origanum vulgare was the most beneficial treatment for improving symptoms and HRQoL (low certainty). Evidence of HMs for acute bacterial rhinosinusitis, chronic rhinosinusitis with nasal polyps, and unclassified chronic rhinosinusitis was restricted to a limited number of studies. Adverse events should be of concern in some HMs, such as Spicae aetheroleum or Mytorl. Several HMs improved patient-important outcomes, above minimal clinically important differences, in treating common cold, acute post-viral rhinosinusitis, and CRSsNP. Further studies with adequate sample sizes and long-term follow-ups are warranted to support the current evidence. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: PROSPERO ID: CRD42022328265 May 10, 2022. © 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

OBJECTIVE: Our review summarizes published literature of complementary and alternative medicine (CAM) used for the treatment of acute bronchitis in children. BACKGROUND: Acute bronchitis is one of the most frequent pediatric diseases and has high prevalence for in- and outpatient care. Acute bronchitis is mainly a viral-caused infection, but a high and inappropriate use of antibiotics has been demonstrated in many countries. As CAM therapies might reduce the use of antibiotics and can complement conventional therapies in children, they could be an appropriate treatment option. METHODS: A systematic literature search was conducted using general and complementary and alternative medicine (CAM)-specific databases. A search term including 65 CAM-associated definitions was applied. RESULTS: Literature search revealed 309 articles, whereby 18 articles hit search criteria. These clinical trials were subgrouped into the categories herbal medicine, anthroposophic medicine and homeopathy. The most often studied approaches are herbal remedies, in particular the Pelargonium sidoides extract, EPs® 7630. Its efficacy was demonstrated in three placebo-controlled trials and two observational studies. Anthroposophic approaches (mainly ribwort-containing remedies) were investigated in two controlled trials and three observational studies. Two studies were found investigating the homeopathic remedies Monapax® and Droperteel®. CONCLUSION: Study results indicate a favorable effect of investigated CAM approaches. However, only three of 18 studies were randomized controlled trials (RCTs), so a reliable statement on effectiveness was not possible and further RCTs are indispensable.

BACKGROUND: Herbal medicines are particularly regarded as an alternative or complement to conventional pharmaceuticals in the treatment and prevention of respiratory tract infections (RTIs). Therefore, the purpose of this review was to identify evidence for herbal therapy in the treatment of RTIs concerning effectiveness and safety. METHODS: Medline/PubMed, Scopus, and the Cochrane Library were searched through February 12, 2015. Randomized controlled trials that compared herbal therapy with no treatment, placebo, or any pharmaceutical medication in children and adolescents (age 0 to 18 years) with RTI were eligible. RESULTS: Eleven trials with 2181 participants were included. No clear evidence for Echinacea (4 trials) or an herbal compound preparation (1 trial) in preventing RTI symptoms was found. Meta-analysis revealed evidence for efficacy (responder rates: risk ratio [RR], 2.56; 95% confidence interval [CI], 1.54-4.26; P < .01; heterogeneity: I2 = 38%; chi-square = 9.63; P = .14) and safety (patients with adverse events: RR, 1.06; 95% CI, 0.42-2.66; P = .9; heterogeneity: I2 = 72%; chi-square = 10.64; P = .01) of Pelargonium sidoides in treating RTI symptoms compared with placebo (6 trials). CONCLUSIONS: Because of conflicting evidence in the included studies no concrete conclusion on effects of Echinacea could be drawn so far. In the case of Pelargonium sidoides, meta-analysis revealed moderate evidence for efficacy and safety in the treatment of RTIs in children.

Herbal medicine is a promising alternative in the treatment of acute rhinosinusitis (ARS). We performed a systematic review for phytopharmaceutical treatments of ARS. A computerized search of databases (Cochrane Library, PubMed, and Scopus) up to 16 September 2015 was performed. Randomized controlled trials (RCTs) and controlled trials (CTs) were included and assessed using the Cochrane risk of bias tool. Seven trials on Pelargonium sidoides (EPs 7630, Umckaloabo®), Myrtol (GeloMyrtol® forte), BNO 1016 (Sinupret® extract), BNO 101 (Sinupret®), Cyclamen europaeum (Nasodren®), and Esberitox® were included. Risk of bias was heterogeneous. EPs 7630 appeared to be useful in the treatment of ARS. Myrtol showed benefits against a placebo compound, and BNO 1016 and BNO 101 might be helpful; however, there was little evidence for the effectiveness of Cyclamen europaeum and Esberitox®. Herbal medicine might be effective for the treatment of ARS, but given the low number of clinical trials and the heterogeneous methodological quality, further research is necessary. © 2016 S. Karger GmbH, Freiburg.

BACKGROUND: Pelargonium sidoides (P. sidoides), also known as Umckaloabo, is a herbal remedy thought to be effective in the treatment of acute respiratory infections (ARIs). OBJECTIVES: To assess the efficacy and safety of P. sidoides for the treatment of ARIs in children and adults. SEARCH METHODS: In April 2013 we searched MEDLINE, Journals@Ovid, The Cochrane Library, Biosis Previews, Web of Science, CINAHL, CCMed, XToxline, Global Health, AMED, Derwent Drug File and Backfile, IPA, ISTPB + ISTP/ISSHP, EMBASE, Cambase, LILACS, PubMed component "Supplied by Publisher", TRIPdatabase, the publisher databases: Deutsches Ärzteblatt, Thieme, Springer, ScienceDirect from Elsevier. We conducted a cited reference search (forward) in Web of Science of relevant papers for inclusion. In addition we searched the study registries ClinicalTrials.gov, Deutsches Register klinischer Studien DRKS (German Clinical Trials Register), International Clinical Trials Registry Platform (ICTRP) - WHO ICTRP, Current Controlled Trials and EU Clinical Trials Register. SELECTION CRITERIA: Double-blind, randomized controlled trials (RCTs) examining the efficacy of P. sidoides preparations in ARIs compared to placebo or any other treatment. Complete resolution of all symptoms was defined as the primary outcome; in addition, we examined resolution of predefined key symptoms. DATA COLLECTION AND ANALYSIS: At least two review authors (AT, JG, WK) independently extracted and quality scored the data. We performed separate analyses by age group and disease entity. Subanalysis considered type of preparation (liquid, tablets). We examined heterogeneity using the I(2) statistic. We calculated pooled risk ratios (RR) using a fixed-effect model if heterogeneity was absent (I(2) < 5%; P > 0.1), or a random-effects model in the presence of heterogeneity. If heterogeneity was substantial (I(2) > 50%; P < 0.10), a pooled effect was not calculated. MAIN RESULTS: Of 10 eligible studies eight were included in the analyses; two were of insufficient quality. Three trials (746 patients, low quality of evidence) of efficacy in acute bronchitis in adults showed effectiveness for most outcomes in the liquid preparatio

Despite widespread use, few empirical data on the efficacy of traditional medicine are available. We conducted systematic reviews of eight widely used African medicines and identified only one plant, Pelargonium sidoides, which has been extensively studied (including in a Cochrane systematic review). To address the need for rigorous science to underpin traditional medicine claims, the South African Herbal Science and Medicine Institute at the University of Western Cape launched the Multi-disciplinary University Traditional Health Initiative (MUTHI) in 2011. The European Union-funded initiative aims to build sustainable research capacity on plants for better public health in Africa. A 2011 needs analysis of clinicians and scientists from 14 African countries confirmed a lack of clinical trial methodology, knowledge and experience. In response, MUTHI deliverables include annual clinical trial methodology workshops in host countries and development of e-learning modules. The initiative provides a unique opportunity for developing African capacity to discover new medicinal products.

An evidence-based systematic review, including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

BACKGROUND: Pelargonium sidoides (P. sidoides), also known as Umckaloabo, is a herbal remedy thought to be effective in the treatment of acute respiratory infections (ARIs). OBJECTIVES: To assess the efficacy and safety of P. sidoides for the treatment of ARIs in children and adults. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 4) which includes the Cochrane Acute Respiratory Infections Group's Specialised Register; MEDLINE (1966 to November 2007); EMBASE (1974 to December 2007); and other electronic databases. SELECTION CRITERIA: Randomized controlled trials (RCTs) examining the efficacy of P. sidoides preparations in ARIs compared to placebo, no treatment or any other treatment. Complete resolution of all symptoms was defined as a primary outcome. DATA COLLECTION AND ANALYSIS: Three review authors (AT, JG, WK) independently extracted and quality scored the data. Separate analyses were performed by age group and disease entity. Heterogeneity was examined using the I-square (I(2)) statistic. Pooled relative risks (RR) were calculated using a fixed-effect model if heterogeneity was absent (I(2) < 5%; P > 0.1), or a random-effects model in the presence of heterogeneity. If heterogeneity was substantial (I(2) > 50%; P < 0.10), a pooled effect was not calculated. MAIN RESULTS: Three trials (746 patients) of efficacy in acute bronchitis in adults showed substantial heterogeneity for all relevant outcomes. and three trials (819 children) were similarly inconsistent for acute bronchitis in children. Type of preparation was a potential cause of heterogeneity (not effective in tablet form). One unpublished study in patients with sinusitis (n = 103 adults) showed significant treatment effects (complete resolution at day 21; RR 0.43, 95% CI 0.30, 0.62). One study in the common cold demonstrating efficacy after 10 days, but not five days. Four trials were excluded because of excessive risk of bias. There were no valid data for the treatment of other acute respiratory tract infections. Adverse events were more common with P. sidoides, but none were serious. AUTHORS' CONCLUSIONS: P. sidoides may be

OBJECTIVE: To critically assess the efficacy of Pelargonium sidoides for treating acute bronchitis. DATA SOURCES: Systematic literature searches were performed in 5 electronic databases: (Medline (1950 - July 2007), Amed (1985 - July 2007), Embase (1974 - July 2007), CINAHL (1982 - July 2007), and The Cochrane Library (Issue 3, 2007) without language restrictions. Reference lists of retrieved articles were searched, and manufacturers contacted for published and unpublished materials. REVIEW METHODS: Study selection was done according to predefined criteria. All randomized clinical trials (RCTs) testing P. sidoides extracts (mono preparations) against placebo or standard treatment in patients with acute bronchitis and assessing clinically relevant outcomes were included. Two reviewers independently selected studies, extracted and validated relevant data. Methodological quality was evaluated using the Jadad score. Meta-analysis was performed using a fixed-effect model for continuous data, reported as weighted mean difference with 95% confidence intervals. RESULTS: Six RCTs met the inclusion criteria, of which 4 were suitable for statistical pooling. Methodological quality of most trials was good. One study compared an extract of P. sidoides, 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. CONCLUSION: There is encouraging evidence from currently available data that P. sidoides is effective compared to placebo for patients with acute bronchitis.