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

Krewel Meuselbach GmbH0 个研究点目标入组 590 人开始时间: 2007年12月28日最近更新: 2012年3月19日

适应症

试验速览

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•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

•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

发起方

Krewel Meuselbach GmbH