Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Common Cold Gastroenteritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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dietary supplement--echinacea, propolis, and vitamin c

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 3-6

Exclusion Criteria

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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michael l macknin, m.d.

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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8348

Identifier Type: -

Identifier Source: org_study_id