Back to resultsEvaluation of Echinacea for the Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Echinacea
Sponsored by
About this trial
This is an interventional prevention trial for Common Cold focused on measuring common cold, Echinacea
Eligibility Criteria
Sites / Locations
- University of Virginia, Charlottesville
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032500
First Posted
March 22, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00032500
Brief Title
Evaluation of Echinacea for the Common Cold
Official Title
Evaluation of Echinacea in a Human Rhinovirus Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
common cold, Echinacea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Echinacea
10. Eligibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B. Turner, MD
Organizational Affiliation
University of Virginia School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. David Gangemi, PhD
Organizational Affiliation
Clemson University
First Name & Middle Initial & Last Name & Degree
Rudolf Bauer, PhD
Organizational Affiliation
Karl-Franzens-Universitaet Graz
Facility Information:
Facility Name
University of Virginia, Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16049208
Citation
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. doi: 10.1056/NEJMoa044441.
Results Reference
result
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Evaluation of Echinacea for the Common Cold
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