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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

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ClinicalTrials.gov Identifier: NCT00231218
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 14, 2006
Sponsor:
Information provided by:
The Cleveland Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Common Cold Gastroenteritis Drug: dietary supplement--echinacea, propolis, and vitamin c Phase 3

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  (Clinical Trial)
Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : January 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. upper respiratory tract infections

Secondary Outcome Measures :
  1. gastroenteritis


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 3-6

Exclusion Criteria:

  • Cystic fibrosis
  • Immunodeficiency
  • Bronchopulmonary dysplasia
  • Anatomic abnormalities of respiratory tract
  • Intestinal malabsorption
  • Allergy to sunflower seeds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231218


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Director: michael l macknin, m.d. The Cleveland Clinic

ClinicalTrials.gov Identifier: NCT00231218     History of Changes
Other Study ID Numbers: 8348
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 14, 2006
Last Verified: December 2006

Keywords provided by The Cleveland Clinic:
vitamin c
echinacea
propolis
upper respiratory tract infection
common cold
gastroenteritis
dietary supplement
herbal remedy

Additional relevant MeSH terms:
Respiratory Tract Infections
Gastroenteritis
Common Cold
Infection
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vitamins
Ascorbic Acid
Propolis
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Infective Agents