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| 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. |
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| 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. |
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| 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 † |
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| 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 | ||||||||||||