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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00032500
Other study ID # R01AT001146-01
Secondary ID
Status Completed
Phase Phase 2
First received March 22, 2002
Last updated August 17, 2006
Start date September 2001
Est. completion date May 2004

Study information

Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

— Not specified —

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Echinacea


Locations

Country Name City State
United States University of Virginia, Charlottesville Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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