drugset / Trial / NCT01021995

Echinacea Safety Study

NCT01021995

Phase 4 Completed 757 enrolled A. Vogel AG
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2009-10
Primary completion
2010-08
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ECHINACEA, UNSPECIFIED Traditional medicine (herbal / TCM) 0.9 ml

Indications