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

Upper Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255307
• Other study ID #: CVT-E002-2005-4
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2005
• Last updated: June 14, 2007
• Start date: November 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2007
• Source: Afexa Life Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Drug:
• CVT-E002 ginseng extract

Locations

Country	Name	City	State
Canada	Misericordia Child Health Clinic	Edmonton	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
CV Technologies	Capital Health, Canada, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To document adverse events related to the short course of American ginseng extract, CVT-E002, in children