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Echinacea, Propolis and Vit c for Uri Prevention in Preschoolers - Article


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Common Cold

Cold, Common 



Clinical Trial: Echinacea, Propolis and Vit c for Uri Prevention in Preschoolers

This study is not yet open for patient recruitment.
Verified by The Cleveland Clinic September 2005

Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00231218

Purpose

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.
Condition Intervention Phase
Common Cold
Gastroenteritis
  Drug: dietary supplement--echinacea, propolis, and vitamin c
 Phase III

MedlinePlus related topics:  Common Cold;   Gastroenteritis

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: the Effectiveness of Echinacea, Propolis and Vitamin c in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study

Further study details as provided by The Cleveland Clinic:
Primary Outcomes: upper respiratory tract infections
Secondary Outcomes: gastroenteritis
Expected Total Enrollment:  104

Study start: January 2006;  Expected completion: March 2006
Last follow-up: March 2006;  Data entry closure: March 2006

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.

Eligibility

Ages Eligible for Study:  3 Years   -   6 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:age 3-6 -

Exclusion Criteria:cystic fibrosis, immunodeficiency, bronchopulmonary dysplasia, anatomic abnormalities of respiratory tract, intestinal malabsorption, allergy to sunflower seeds

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00231218

michael l macknin, m.d.      216-444-5512    macknim@ccf.org

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
michael l macknin, m.d.  216-444-5512    macknim@ccf.org 
michael l macknin, m.d.,  Principal Investigator

Study chairs or principal investigators

michael l macknin, m.d.,  Study Director,  The Cleveland Clinic   

More Information

Study ID Numbers:  8348
Last Updated:  December 8, 2005
Record first received:  September 30, 2005
ClinicalTrials.gov Identifier:  NCT00231218
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006

Resources



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November 24, 2009


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