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Home > "A" Clinical Trials Conditions > A Randomized Controlled Trial of Echinacea in Children  A Randomized Controlled Trial of Echinacea in Children
A Randomized Controlled Trial of Echinacea in Children
For Condition: Common Cold
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.
Details: Upper respiratory tract infections (URI's) are a significant health burden in childhood. URI's are a major reason for visits to health care providers, and up to 35 percent of young children at any given time are taking some over-the-counter cold medication. Unfortunately, data suggest that most of these medications have limited effectiveness. Alternative medical therapies are growing in popularity; in a recent survey of parents of children being seen by pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen by an alternative medicine health care provider, and 53.3 percent received therapies for the treatment of URI's in children. The proposed study is a randomized, double blind, placebo controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims of the project are: to determine if Echinacea shortens the duration and/or lessens the severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11 years old is associated with any significant side effects. A two-year study of 600 children is planned. Not only will the results of this study determine if Echinacea, the most popular medicinal herb sold in the United States, is an effective therapy for URI's in children, the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/11 Years
Genders: Both
Protocol Entry Criteria: Children 2 through 11 years old. Parent available to observe child during the night. Parent speaks and reads English. Child has no history of asthma, allergic rhinitis. Child has no history of auto-immune disease. Child has no history of chronic lung disease. Child has no known allergy to sunflower species.
Total Enrollment: 600
Location and Contact Information:
Child Health Institute, University of Washington
Seattle, Washington, 98103
United States
Additional Information:
Study ID Numbers: 1 R01 AT00114-01;
Study Start Date: April 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029211
Other Common Cold Studies:
1. A Randomized Controlled Trial of Echinacea in Children
2. Echinacea Versus Placebo Effect in Common Cold
3. Evaluation of Echinacea for the Common Cold
Related Studies:
Other Common Cold Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
A Randomized Controlled Trial of Echinacea in Children
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