Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.

Sponsor

CV Technologies (Industry)

Overall Status

Completed

CT.gov ID

NCT00255307

Collaborator

University of Alberta (Other), Capital Health, Canada (Other)

Enrollment

Locations

Duration (Months)

37.5

Patients Per Site

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Infection	Drug: CVT-E002 ginseng extract	Phase 2

Detailed Description

The eligible children, for whom parental consent has been obtained, will be randomized to one of three groups (standard dose, low dose, or placebo). The standard dose group will receive an oral aqueous solution using the standard dose of CVT-E002, adjusted according to the child's weight. The second group will receive an oral aqueous solution with half of the standard dose of CVT-E002, adjusted according to the child's weight, and the third group will receive a placebo as an aqueous solution of starch that does not contain any CVT-E002 or active medication, volume adjusted for the child's weight. Parents will be provided with a 3-day supply of study medication according to the randomization schedule. CVT-E002 will be administered by the parent to the child three times daily for three consecutive days following the onset of a URTI. Severity and duration of URTI will be measured using the reliable and valid Canadian Acute Respiratory Infection Flu Score (CARIFS).

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Pilot Evaluation of Two Dosing Schedules of American Ginseng Extract in Pediatric Upper Respiratory Tract Infection.

Study Start Date :

Nov 1, 2005

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

To establish preliminary estimate of treatment effect of two doses of American ginseng extract, CVT-E002, in reducing severity and duration of URTI in children []

Secondary Outcome Measures

To document adverse events related to the short course of American ginseng extract, CVT-E002, in children []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children aged 3-12 years who present to their pediatrician with in 48 hours of the onset of an acute upper respiratory tract infection.
signed informed consent form

Exclusion Criteria:

Children who have had an immunization in 3 months prior to the study
Children with known hypoglycemia or diabetes
Children who have a bacterial illness diagnosed at the same visit (e.g. otitis media, pneumonia, etc.) which will be treated with antibiotic therapy
Children who have a malignancy or who have undergone treatment for a malignancy in the previous three months
Children with known active liver disease (e.g. hepatitis)
Known hypersensitivity to ginseng products
Concurrent treatment with warfarin, digoxin, ginseng products or phenelzine
Patients with coagulation disorders