Status:
COMPLETED
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.
Lead Sponsor:
CV Technologies
Collaborating Sponsors:
University of Alberta
Capital Health, Canada
Conditions:
Upper Respiratory Infection
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
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 st...
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 aqueou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00255307
Start Date
November 1 2005
End Date
April 1 2006
Last Update
June 18 2007
Active Locations (2)
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1
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2R7
2
Misericordia Child Health Clinic
Edmonton, Alberta, Canada