Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

The Cleveland Clinic104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

104

Conditions

Common Cold Gastroenteritis

Interventions

dietary supplement--echinacea, propolis, and vitamin cDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 3-6 Exclusion Criteria: * Cystic fibrosis * Immunodeficiency * Bronchopulmonary dysplasia * Anatomic abnormalities of respiratory tract * Intestinal malabsorption * Allergy to sunflower seeds

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

upper respiratory tract infections

Secondary Outcomes

gastroenteritis

Data from ClinicalTrials.gov

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