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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 4, 2005
Last Update Posted: December 14, 2006
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.
Information provided by:
The Cleveland Clinic
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
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

Resource links provided by NLM:

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.

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

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
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

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

ClinicalTrials.gov Identifier: NCT00231218     History of Changes
Other Study ID Numbers: 8348
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: December 14, 2006
Last Verified: December 2006

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

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