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A Trial of Echinacea in Children

This study has been completed.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00029211
  Purpose

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.


Condition Intervention Phase
Common Cold
Drug: Echinacea
Phase III

MedlinePlus related topics:   Common Cold   

ChemIDplus related topics:   Coneflower extract   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized Controlled Trial of Echinacea in Children

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   600
Study Start Date:   April 2000
Estimated Study Completion Date:   March 2003

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.

  Eligibility
Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029211

Locations
United States, Washington
Child Health Institute, University of Washington    
      Seattle, Washington, United States, 98103

Sponsors and Collaborators

Investigators
Principal Investigator:     James Taylor, MD     University of Washington    
  More Information


Study ID Numbers:   R01 AT000114-01
First Received:   January 9, 2002
Last Updated:   August 17, 2006
ClinicalTrials.gov Identifier:   NCT00029211
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Common Cold
Picornaviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on October 10, 2008




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