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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

Primary Purpose

Common Cold, Gastroenteritis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

dietary supplement--echinacea, propolis, and vitamin c

About this trial

This is an interventional prevention trial for Common Cold focused on measuring vitamin c, echinacea, propolis, upper respiratory tract infection, common cold, gastroenteritis, dietary supplement, herbal remedy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts 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

Sites / Locations

Cleveland Clinic Foundation

Outcomes

Primary Outcome Measures

upper respiratory tract infections

Secondary Outcome Measures

gastroenteritis

Full Information

NCT ID

NCT00231218

First Posted

September 30, 2005

Last Updated

December 13, 2006

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00231218

Brief Title

Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

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 Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

The Cleveland Clinic

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Cold, Gastroenteritis

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

104 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dietary supplement--echinacea, propolis, and vitamin c

Primary Outcome Measure Information:

Title

upper respiratory tract infections

Secondary Outcome Measure Information:

Title

gastroenteritis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

michael l macknin, m.d.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Study Director

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

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