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A Trial of Echinacea in Children

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  A Trial of Echinacea in Children
Official Title  A Randomized Controlled Trial of Echinacea in Children
Brief Summary

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.

Detailed Description

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Common Cold
Intervention  Drug: Echinacea
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  600
Start Date  April 2000
Completion Date March 2003
Eligibility Criteria 

Inclusion Criteria:

  • Parent available to observe child during the night
  • Parent peaks and reads English

Exclusion Criteria:

  • History of asthma or allergic rhinitis
  • History of auto-immune disease
  • History of chronic lung disease
  • Allergy to sunflower species
Gender Both
Ages 2 Years to 11 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00029211
Organization ID R01 AT000114-01
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators †† Office of Dietary Supplements (ODS)
Investigators 
Principal Investigator:     James Taylor, MD     University of Washington    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  January 9, 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.




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