Echinacea, Propolis and Vitamin C for URI Prevention in P... | NCT00231218

Studies
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

NCT00231218

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Dec 14, 2006Estimated

Enrollment

104

Phase

Phase 3

Conditions

Common Cold
Gastroenteritis

Interventions

dietary supplement--echinacea, propolis, and vitamin c

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Sep 30, 2005

First Submission Date that Met QC Criteria

Sep 30, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2006

Last Update Posted Date

Dec 14, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104

Name	Type	Description	Arm Group Labels	Other Names
dietary supplement--echinacea, propolis, and vitamin c	Drug

Measure	Description	Time Frame
upper respiratory tract infections

Measure	Description	Time Frame
gastroenteritis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 3-6

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
michael l macknin, m.d.	The Cleveland Clinic	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio	44195	United States

Condition Browse Module

MeSH Terms

ID	Term
D003139	Common Cold
D005759	Gastroenteritis
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011429	Propolis
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D012116	Resins, Plant
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided