Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Phase 3

Completed

• Conditions: Common Cold; Gastroenteritis

• Registration Number: NCT00231218
• Lead Sponsor: The Cleveland Clinic

Brief 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.

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.

Study Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Study Start: 2006-01
• Study Completion: 2006-03
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-13
• Last Update Posted: 2006-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
upper respiratory tract infections

Secondary Outcome Measures

Name	Time	Method
gastroenteritis

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States