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Evaluation of Echinacea for the Common Cold

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00032500
First received: March 22, 2002
Last updated: August 17, 2006
Last verified: July 2006

March 22, 2002
August 17, 2006
September 2001
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Complete list of historical versions of study NCT00032500 on ClinicalTrials.gov Archive Site
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Evaluation of Echinacea for the Common Cold
Evaluation of Echinacea in a Human Rhinovirus Challenge

The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.

Echinacea is a widely used herbal remedy for the common cold. Previous clinical trials designed to assess the efficacy of Echinacea for prevention or treatment of the common cold have produced inconsistent results. A variety of different Echinacea products have been used in these clinical trials. Recent studies indicate that different Echinacea preparations have dramatically different phytochemical profiles. The available clinical trial data provide no information about the potential role of the different constituents of Echinacea in common cold prevention or treatment. Our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the Echinacea preparations used. This study will address the following specific aims: 1) Evaluate the effectiveness of chemically defined extracts of E. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) Assess the correlation between specific Echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) Determine the effect of different Echinacea preparations on the host response to rhinovirus infection.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Common Cold
Drug: Echinacea
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Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi JD. An evaluation of Echinacea angustifolia in experimental rhinovirus infections. N Engl J Med. 2005 Jul 28;353(4):341-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2004
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032500
R01 AT001146-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Ronald B. Turner, MD University of Virginia School of Medicine
Investigator: J. David Gangemi, PhD Clemson University
Investigator: Rudolf Bauer, PhD Karl-Franzens-Universitaet Graz
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP