Evaluation of Echinacea for the Common Cold - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Evaluation of Echinacea for the Common Cold

Official Title ^†

Evaluation of Echinacea in a Human Rhinovirus Challenge

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Common Cold

Intervention ^†

Drug: Echinacea

MEDLINE PMIDs

16049208

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2001

Completion Date

May 2004

Eligibility Criteria ^†

Gender

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00032500

Organization ID

R01 AT001146-01

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

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

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2006

First Received Date ^†

March 22, 2002

Last Updated Date

August 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.