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A Trial of Echinacea in Children

Primary Purpose

Common Cold

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Echinacea
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Child Health Institute, University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00029211
Brief Title
A Trial of Echinacea in Children
Official Title
A Randomized Controlled Trial of Echinacea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Echinacea

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Taylor, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Health Institute, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States

12. IPD Sharing Statement

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A Trial of Echinacea in Children

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