Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 8:54 PM
Study NCT ID:
NCT05916768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-30
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Acute Bronchitis With Pelargonium Sidoides Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-20', 'size': 353822, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-22T04:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 412}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Pelargonium sidoides extract EPs® 7630', 'timeFrame': '22 days', 'description': '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.'}, {'measure': 'Proportion of patients taking antibiotics', 'timeFrame': '22 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Integration of a herbal medicinal product in conventional settings', 'timeFrame': '22 days', 'description': 'Proportion of primary care physicians (PCPs) who agreed to participate in the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelargonium sidoides'], 'conditions': ['Acute Bronchitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe main questions it aims to answer are:\n\n* Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ?\n* Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics?\n\nParticipants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.\n\nExclusion Criteria:\n\n* Infection requiring antibiotic treatment (ex. cystic fibrosis)\n* Pneumonia\n* Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication\n* Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)\n* Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)\n* Inability to fill out the diary (no ability to read and understand French)\n* Pregnancy or breastfeeding\n* Immunological deficiencies\n* Hospitalization\n* Severe hepatic disease\n* Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)\n* Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)\n* If the patient is taking a drug among these classes of drugs:\n\nanticoagulants, immunosuppressants, chemotherapy or immunotherapy'}, 'identificationModule': {'nctId': 'NCT05916768', 'acronym': 'Phytobronch', 'briefTitle': 'Management of Acute Bronchitis With Pelargonium Sidoides Extract', 'organization': {'class': 'OTHER', 'fullName': 'University of Fribourg'}, 'officialTitle': 'Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2023-00125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The solution of Pelargonium sidoides extract EPs® 7630:\n\n3x30 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.', 'interventionNames': ['Other: Pelargonium sidoides extract EPs® 7630']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'Pelargonium sidoides extract EPs® 7630', 'type': 'OTHER', 'description': 'Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).', 'armGroupLabels': ['Intervention group']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'symptomatic treatments', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1700', 'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'University of Fribourg', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}], 'overallOfficials': [{'name': 'Pierre-Yves Rodondi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Fribourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Fribourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}