NCT01021995

Echinacea Safety Study

Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: A. Vogel AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections

Interventions

Type	Name	Description
DRUG	echinacea	drops, 0.9 ml, tid for 4 months
DRUG	placebo	drops, 0.9 ml tid for 4 months

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2011-04-01
• First posted: 2009-12-01
• Last updated: 2014-07-23

Locations

1 site across 1 country: United Kingdom