Acute Bronchitis
Conditions
Keywords
pelargonium sidoides
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).
Interventions
OTHERPelargonium sidoides extract EPs® 7630
Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
OTHERusual care
symptomatic treatments
Sponsors
University of Fribourg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Integration of a herbal medicinal product in conventional settings | 22 days | Proportion of primary care physicians (PCPs) who agreed to participate in the study |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORPierre-Yves Rodondi, Prof.
University of Fribourg
Outcome results
None listed