Management of Acute Bronchitis With Pelargonium Sidoides Extract
- Conditions
- Acute Bronchitis
- Registration Number
- NCT05916768
- Lead Sponsor
- University of Fribourg
- Brief Summary
The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract, EPs® 7630, in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland. The RCT will be preceded by a pilot phase to ensure its feasibility.
- Detailed Description
The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs® 7630, also known under the brand name Kaloba®, in the management of acute bronchitis.
The main questions it aims to answer are:
* Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ?
* Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics?
Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 412
- Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis.
- Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.
- Infection requiring antibiotic treatment (ex. cystic fibrosis)
- Pneumonia
- Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication
- Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)
- Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)
- Inability to fill out the diary (no ability to read and understand French)
- Pregnancy or breastfeeding
- Immunological deficiencies
- Hospitalization
- Severe hepatic disease
- Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)
- Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)
- If the patient is taking a drug among these classes of drugs:
anticoagulants, immunosuppressants, chemotherapy or immunotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effectiveness of Pelargonium sidoides extract EPs® 7630 22 days Effectiveness will be determined by comparing the number of days needed to achieve a 50% reduction in the ABSS score after peak of symptoms in each group.
Proportion of patients taking antibiotics 22 days The co-medication, including antibiotics, will be collected by the investigator at day 4, 8 and 22. The results will be compared between the two arms.
- Secondary Outcome Measures
Name Time Method Integration of a herbal medicinal product in conventional settings 22 days Proportion of primary care physicians (PCPs) who agreed to participate in the study
Trial Locations
- Locations (1)
University of Fribourg
🇨🇭Fribourg, Switzerland
University of Fribourg🇨🇭Fribourg, Switzerland