Management of Acute Bronchitis With Pelargonium Sidoides Extract

NCT05916768 | Completed

• 1 other identifier: 2023-00125
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchitis

Keywords

pelargonium sidoides

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Integration of a herbal medicinal product in conventional settings

  22 days

Study Arms (2)

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.

Other: Pelargonium sidoides extract EPs® 7630

Control group

ACTIVE COMPARATOR

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

Other: usual care

Interventions

Pelargonium sidoides extract EPs® 7630 OTHER

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

Intervention group

usual care OTHER

symptomatic treatments

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Fribourg: lead

Study Sites (1)

University of Fribourg

Fribourg, Canton of Fribourg, 1700, Switzerland

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Pierre-Yves Rodondi, Prof.

  University of Fribourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: May 15, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)