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

This study has been completed.
Sponsor:
Collaborators:
University of Alberta
Capital Health, Canada
Information provided by:
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00255307
First received: November 16, 2005
Last updated: June 14, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Upper Respiratory Infection
Drug: CVT-E002 ginseng extract
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of Two Dosing Schedules of American Ginseng Extract in Pediatric Upper Respiratory Tract Infection.

Further study details as provided by Afexa Life Sciences Inc:

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

Enrollment: 75
Study Start Date: November 2005
Study Completion Date: April 2006
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).

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255307

Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2R7
Misericordia Child Health Clinic
Edmonton, Alberta, Canada
Sponsors and Collaborators
CV Technologies
University of Alberta
Capital Health, Canada
Investigators
Principal Investigator: Sunita Vohra, MD University of Alberta/Capital Health
  More Information

No publications provided by Afexa Life Sciences Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00255307     History of Changes
Other Study ID Numbers: CVT-E002-2005-4
Study First Received: November 16, 2005
Last Updated: June 14, 2007
Health Authority: Canada: Health Canada

Keywords provided by Afexa Life Sciences Inc:
cold
flu
respiratory tract infection

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014