A Trial of Echinacea in Children

Phase 3

Completed

• Conditions: Common Cold

• Registration Number: NCT00029211
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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 Timeline

• Study Start: 2000-04
• Study First Submitted: 2002-01-09
• Study First Submitted QC: 2002-01-09
• Study First Posted: 2002-01-10
• Study Completion: 2003-03
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-17
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Child Health Institute, University of Washington; 🇺🇸 Seattle, Washington, United States