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Echinacea Safety Study

NCT01021995 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2014-07-23

No results posted yet for this study

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

Interventions

DRUG

echinacea

drops, 0.9 ml, tid for 4 months

DRUG

placebo

drops, 0.9 ml tid for 4 months

Sponsors & Collaborators

  • A. Vogel AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2011-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021995 on ClinicalTrials.gov