Common Cold |
Cold, Common |
Clinical Trial: A Trial of Echinacea in Children
This study is no longer recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Common Cold | Drug: Echinacea | Phase III |
MedlinePlus related topics: Common Cold
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
Expected Total Enrollment: 600
Study start: April 2000; Study completion: March 2002
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 - 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
Location Information
Washington
Child Health Institute, University of Washington, Seattle, Washington, 98103, United States
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: January 9, 2002
ClinicalTrials.gov Identifier: NCT00029211
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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