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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

This study has been completed.
Information provided by:
The Cleveland Clinic Identifier:
First received: September 30, 2005
Last updated: December 13, 2006
Last verified: December 2006

September 30, 2005
December 13, 2006
January 2006
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upper respiratory tract infections
Same as current
Complete list of historical versions of study NCT00231218 on Archive Site
Same as current
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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Common Cold
  • Gastroenteritis
Drug: dietary supplement--echinacea, propolis, and vitamin c
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2006
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Inclusion Criteria:

  • Age 3-6

Exclusion Criteria:

  • Cystic fibrosis
  • Immunodeficiency
  • Bronchopulmonary dysplasia
  • Anatomic abnormalities of respiratory tract
  • Intestinal malabsorption
  • Allergy to sunflower seeds
Sexes Eligible for Study: All
3 Years to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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The Cleveland Clinic
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Study Director: michael l macknin, m.d. The Cleveland Clinic
The Cleveland Clinic
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP