ClinicalTrials.gg
CompletedNCT05916768PhytobronchUpdated Jan 16, 2026

Management of Acute Bronchitis With Pelargonium Sidoides Extract

An interventional study of Pelargonium sidoides extract EPs® 7630 and usual care in Acute Bronchitis, sponsored by University of Fribourg. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University of Fribourg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Acute Bronchitis

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Keywords

  • pelargonium sidoides
03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's enrollment of 332 is above the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

University of Fribourg is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Infection requiring antibiotic treatment (ex. cystic fibrosis)
  • Pneumonia
  • Known to Pelargonium sidoides extract or of the trial medication
  • Non-infectious causes (, 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, , chemotherapy or immunotherapy

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
332 participants (actual)

Study arms

  • Experimental
    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.

    Other: Pelargonium sidoides extract EPs® 7630

  • Active comparator
    Control group

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

    Other: usual care

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 22 days

  2. 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.

    Time frame: 22 days

Secondary outcomes

  1. Integration of a herbal medicinal product in conventional settings

    Proportion of primary care physicians (PCPs) who agreed to participate in the study

    Time frame: 22 days

07

Study locations

1 site
  • University of Fribourg
    Fribourg, Canton of Fribourg 1700, Switzerland
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Apr 2025, 23 months.

Of 16 interventional studies with no phase under Bronchitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 23 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2023
First posted
Jun 23, 2023
StartActual
May 15, 2023
Primary completionActual
Apr 24, 2025
CompletionActual
Apr 24, 2025
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05916768
Lead sponsor
University of Fribourg
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
May 15, 2023
Primary completion
Apr 24, 2025
Completion
Apr 24, 2025
Last update
Jan 16, 2026

Study contacts

Pierre-Yves Rodondi, Prof.
principal investigator · University of Fribourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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