Acute BronchitisPhytobronchNCT05916768
Management of Acute Bronchitis With Pelargonium Sidoides Extract
A study testing Pelargonium sidoides extract EPs® 7630 in people with Acute Bronchitis, run by University of Fribourg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Pelargonium sidoides extract EPs® 7630
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2023to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Fribourg
Fribourg, Canton of Fribourg, 1700
About this study
Official title: Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial
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).
- Conditions
- Acute Bronchitis
- Being tested
- Pelargonium sidoides extract EPs® 7630, usual care
- Keywords
- pelargonium sidoides
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelargonium sidoides extract EPs® 7630Other
Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
usual careOther
symptomatic treatments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start15 May 2023
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Rodondi, Prof., Principal investigator, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916768
- Sponsor's protocol ID
- 2023-00125
- Other IDs
- 2023
- Acronym
- Phytobronch
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05916768
- Acronym / sponsor ID
- Phytobronch / 2023-00125
- Conditions
- Acute Bronchitis
- Keywords
- pelargonium sidoides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pelargonium sidoides extract EPs® 7630The 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 | Other: usual careUsual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelargonium sidoides extract EPs® 7630Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630). | Other | Intervention group |
| usual caresymptomatic treatments | Other | Control group |
Primary outcome
Effectiveness of Pelargonium sidoides extract EPs® 7630
Time frame: 22 days
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.
Proportion of patients taking antibiotics
Time frame: 22 days
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.
1 secondary outcome
Integration of a herbal medicinal product in conventional settings
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Rodondi, Prof. principal investigator
University of Fribourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelargonium sidoides extract EPs® 7630 in people with Acute Bronchitis, run by University of Fribourg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Pelargonium sidoides extract EPs® 7630 (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.