Echinacea Safety Study
Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.
Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.
Common cold related symptoms will be recorded in a daily diary.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months|
- Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
drops, 0.9 ml, tid for 4 months
|Placebo Comparator: placebo||
drops, 0.9 ml tid for 4 months