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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.
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:
Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | Active Comparator | Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelargonium sidoides extract EPs® 7630 | Other | Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Pelargonium sidoides extract EPs® 7630 | 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. | 22 days |
| Proportion of patients taking antibiotics | 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. | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Integration of a herbal medicinal product in conventional settings | Proportion of primary care physicians (PCPs) who agreed to participate in the study | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
anticoagulants, immunosuppressants, chemotherapy or immunotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Rodondi, Prof. | University of Fribourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Fribourg | Fribourg | Canton of Fribourg | 1700 | Switzerland |
anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2025 | Apr 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| usual care | Other | symptomatic treatments |
|
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |