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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00231218
First received: September 30, 2005
Last updated: December 13, 2006
Last verified: December 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • upper respiratory tract infections

Secondary Outcome Measures:
  • gastroenteritis

Estimated Enrollment: 104
Study Start Date: January 2006
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00231218     History of Changes
Other Study ID Numbers: 8348
Study First Received: September 30, 2005
Last Updated: December 13, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013