Management of Acute Bronchitis With Pelargonium Sidoides Extract
- Conditions
- Acute Bronchitis
- Interventions
- Other: usual careOther: Pelargonium sidoides extract EPs® 7630
- 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
- Arm && Interventions
Group Intervention Description Control group usual care Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy Intervention group Pelargonium sidoides extract EPs® 7630 The solution of Pelargonium sidoides extract EPs® 7630: 3x30 drops/day for 7 days and will be advised to pursue the treatment until the end of symptoms if bothered by the cough up to a maximum of 21 days.
- 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