Echinacea Safety Study
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|ClinicalTrials.gov Identifier: NCT01021995|
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : July 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Infections||Drug: echinacea Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||757 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months|
|Study Start Date :||October 2009|
|Primary Completion Date :||August 2010|
|Study Completion Date :||April 2011|
drops, 0.9 ml, tid for 4 months
|Placebo Comparator: placebo||
drops, 0.9 ml tid for 4 months
- Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ]
- efficacy [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021995
|Cardiff School of Biosciences|
|Cardiff, Wales, United Kingdom, CF103AX|