Management of Acute Bronchitis With Pelargonium Sidoides Extract

NCT ID: NCT05916768

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-04-24

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).

Conditions

Acute Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Pelargonium sidoides extract EPs® 7630

Intervention Type: OTHER

Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).

Control group

Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

symptomatic treatments

Interventions

Pelargonium sidoides extract EPs® 7630

Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).

Intervention Type: OTHER

usual care

symptomatic treatments

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Fribourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Yves Rodondi, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Fribourg

Locations

University of Fribourg

Fribourg, Canton of Fribourg, Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-00125

Identifier Type: -

Identifier Source: org_study_id