Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231218

Enrollment

104

Registered

2005-10-04

Start date

2006-01-31

Completion date

2006-03-31

Last updated

2006-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold, Gastroenteritis

Keywords

vitamin c, echinacea, propolis, upper respiratory tract infection, common cold, gastroenteritis, dietary supplement, herbal remedy

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.

Interventions

DRUGdietary supplement--echinacea, propolis, and vitamin c

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 3-6

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
upper respiratory tract infections	—

Secondary

Measure	Time frame
gastroenteritis	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026