- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00231218
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
December 13, 2006 updated by: The Cleveland Clinic
the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study
We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This combination of herbs has been studied only once before in preschoolers.
In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138).
We are repeating this study to see if our results confirm or contradict those of the previous study.
Study Type
Interventional
Enrollment
104
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 3-6
Exclusion Criteria:
- Cystic fibrosis
- Immunodeficiency
- Bronchopulmonary dysplasia
- Anatomic abnormalities of respiratory tract
- Intestinal malabsorption
- Allergy to sunflower seeds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
upper respiratory tract infections
|
Secondary Outcome Measures
Outcome Measure |
---|
gastroenteritis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael L Macknin, M.D., The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
September 30, 2005
First Submitted That Met QC Criteria
September 30, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
December 14, 2006
Last Update Submitted That Met QC Criteria
December 13, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Gastrointestinal Diseases
- Picornaviridae Infections
- Gastroenteritis
- Respiratory Tract Infections
- Common Cold
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
- Propolis
Other Study ID Numbers
- 8348 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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