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	Treatment or Intervention	Phase
Common Cold	Drug: Echinacea	Phase III

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.

Ages Eligible for Study:  2 Years   -   11 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

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

Study ID Numbers:  1 R01 AT00114-01
Record last reviewed:  September 2004
Record first received:  January 9, 2002
ClinicalTrials.gov Identifier:  NCT00029211
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29