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

Official Title: “A Pilot Evaluation of Two Dosing Schedules of American Ginseng Extract in Pediatric Upper Respiratory Tract Infection.”

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.

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).

Intervention(s) in this Clinical Trial

• Drug: CVT-E002 ginseng extract

Primary 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 Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: CV Technologies Industry

Overall Clinical Trial Officials and Contacts

Sunita Vohra, MD Principal Investigator University of Alberta/Capital Health  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255307

Study ID Number: CVT-E002-2005-4

ClinicalTrials.gov Identifier: NCT00255307

Health Authority: Canada: Health Canada