Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Gastroenteritis; Common Cold

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00231218

8348

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 3-6

Exclusion criteria

• Cystic fibrosis
• Immunodeficiency
• Bronchopulmonary dysplasia
• Anatomic abnormalities of respiratory tract
• Intestinal malabsorption
• Allergy to sunflower seeds

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind