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NCT00231218 Clinical Trial

Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00231218
Other study ID # 8348
Secondary ID
Status Completed
Phase Phase 3
First received September 30, 2005
Last updated December 13, 2006
Start date January 2006
Est. completion date March 2006

Study information
Verified date December 2006
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- Age 3-6

Exclusion Criteria:

- Cystic fibrosis

- Immunodeficiency

- Bronchopulmonary dysplasia

- Anatomic abnormalities of respiratory tract

- Intestinal malabsorption

- Allergy to sunflower seeds

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• dietary supplement--echinacea, propolis, and vitamin c

Locations
Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary upper respiratory tract infections
Secondary gastroenteritis
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