Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis
- Conditions
- Acute bronchitisMedDRA version: 20.1Level: LLTClassification code: 10000687Term: Acute bronchitis Class: 10021881Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-507370-41-00
- Lead Sponsor
- Engelhard Arzneimittel GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Acute bronchitis with symptoms that have been present for 48-72 hours prior to treatment, Male or female patients of any ethnic origin, Age: 18 – 75 years, inclusive, Patients who are able to understand and are willing to follow the study rules, Patients who have given their written informed consent to participate in the study, With the exception of the existing bronchitis, good state of health as judged by the investigator based on medical history and physical examination, CS score of at least 50 mm on the 100 mm VAS at visit V1, BSS of at least 10 points at visit V1, VCD score of at least 2 points at visit V1
Allergic bronchial asthma, bronchial hyperresponsiveness, chronic bronchitis, other chronic or hereditary lung diseases, Any other phytopharmaceutical medication (e.g. pelargonium extracts or other ivy preparations) or homeopathic medicines for the common cold within the last 7 days before visit V1, Patients who have been strictly forbidden by their doctor to take minimal amounts of alcohol (e.g., after a detoxification cure), Medication, drug or alcohol abuse as judged by the investigator, Pregnant or lactating women, Body temperature >38.3°C, Women of childbearing potential who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol; Definition of women of childbearing potential and post-menopausal women is given in chapter 4.2.8 of the clinical trial protocol.), Patients suffering from a significant condition, defined as a condition which, at the discretion of the investigator, either exposes the patient to a risk by participating in the study, or which affects the results of the study or the ability of the patient to participate in the study. This criterion includes patients with a history of gastrointestinal bleeding, significant cardiovascular, hepatic or renal disease., Patients directly or indirectly involved in the conduct of this study, including employees of the sponsor, CRO and their relatives, History of hypersensitivity to any of the constituents of the IMPs, History of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis or current hay fever, History of chronic gastritis or peptic ulcer, Any gastrointestinal complaints within the last 7 days before visit V1, Patients with known hereditary fructose-intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency, Participation in a clinical trial within the last 30 days prior to the treatment phase of this study, Simultaneous participation in another clinical trial with active ingredients, Treatment with corticoids, beta-2 agonists (e.g., salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g., Aspirin with daily dose > 100mg) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, ACE inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate within the last 7 days before visit V1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method