Acute bronchitis therapy with ivy leaves extracts in a two-arm study: a double-blind, ransomised study vs. comparator - Hedlix Ability Study

• Conditions: acute bronchitis; MedDRA version: 9.1Level: PTClassification code 10006452Term: Bronchitis acute

• Registration Number: EUCTR2007-003272-19-CZ
• Lead Sponsor: Krewel Meuselbach GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

1. Patient and/or legal guardian is/are able to understand written and/or oral information on the study and has/have given written informed consent prior to participation in the study; in the case of patients not yet of age, but able to understand information on the study, the pa-tient’s consent may be oral, but the consent of the legal guardian/s must be in writing
2. Male or female, Caucasian, at least 2 years of age
3. Confirmed clinical diagnosis of acute bronchitis with a BSS = 5
4. Duration of complaints not more than 48 hours
5. Prepared to comply with the study schedule regarding study medication use, non-use of concomitant medication, and visits
6. In female patients of childbearing potential: negative pregnancy test
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of drugs or household remedies for this episode of acute bronchitis
2. Therapy with antibiotics or corticosteroids in the four weeks before the study
3. Use of cold medications” or cold prophylactics” during the preceding two weeks
4. Use of antihistamines during the preceding week
5. Use of above medications intended during the study
6. Use of throat lozenges within four hours before the admission examination
7. Use of long-acting beta-2 agonists within 24 hours before the admission examination
8. Use of short-acting beta-2 agonists within eight hours before the admission examination
9. Known hypersensitivity or allergy to ivy leaves extracts
10. Bacterial infection or other indication for therapy with antibiotics
11. Allergic asthma or bronchial hyperreactivity
12. Chronic bronchitis or other chronic or inherited lung diseases
13. Severe cardiac, hepatic, or renal disorders
14. Arginine succinate synthetase deficiency (metabolic disorder of the urea cycle)
15. Evidence of congenital, acquired, or drug or malignancy induced immunodeficiency
16. Previous or concurrent cancer
17. Drug, illicit substance, or alcohol abuse or other factors suggesting questionable compli-ance
18. Pregnancy or lactation
19. Participation in another clinical trial within three months prior to this study
20. Previous participation in this trial
21. Involved in the performance of this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified