Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029211
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-09
Brief Title:
A Trial of Echinacea in Children
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
A Randomized Controlled Trial of Echinacea in Children
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized trial to determine if echinacea is effective in shortening the length andor lessening the severity of colds in children 2 through 11 years old
Detailed Description:
Upper respiratory tract infections URIs are a significant health burden in childhood URIs 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 242 percent indicated that their child had been seen by an alternative medicine health care provider and 533 percent received therapies for the treatment of URIs in children The proposed study is a randomized double blind placebo controlled trial of Echinacea for the treatment of URIs in children 2-11 years old The aims of the project are to determine if Echinacea shortens the duration andor lessens the severity of URIs if children receiving Echinacea for treatment of URIs 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 URIs in children the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None