Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00231218

Collaborator

(none)

104

Enrollment

Location

1.9

Duration (Months)

53.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold Gastroenteritis	Drug: dietary supplement--echinacea, propolis, and vitamin c	Phase 3

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 Design

Study Type:

Interventional

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

Study Start Date :

Jan 1, 2006

Study Completion Date :

Mar 1, 2006