A Trial of Echinacea in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00029211
First received: January 9, 2002
Last updated: August 17, 2006
Last verified: August 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Echinacea in Children

Resource links provided by NLM:


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

No publications provided

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

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014