A Trial of Echinacea in Children

Common Cold Clinical Trial

Official title:

A Randomized Controlled Trial of Echinacea in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029211
• Other study ID #: R01AT000114-01
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2002
• Last updated: August 17, 2006
• Start date: April 2000
• Est. completion date: March 2003

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Echinacea

Locations

Country	Name	City	State
United States	Child Health Institute, University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States,