NCT05916768

Management of Acute Bronchitis With Pelargonium Sidoides Extract

Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: University of Fribourg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
OTHER	Pelargonium sidoides extract EPs® 7630	Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
OTHER	usual care	symptomatic treatments

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2023-06-23
• Last updated: 2026-01-16

Locations

1 site across 1 country: Switzerland