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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CV Technologies
• Collaborators: Capital Health, Canada; University of Alberta

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