Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231218
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 14, 2006
Information provided by:
The Cleveland Clinic

September 30, 2005
October 4, 2005
December 14, 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
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.
Same as current
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