Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.
A Pilot Evaluation of Two Dosing Schedules of American Ginseng Extract in Pediatric Upper Respiratory Tract Infection.
1 other identifier
interventional
75
1 country
2
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 standard doses reduces the duration of URTI in children aged 3-12 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 16, 2005
CompletedFirst Posted
Study publicly available on registry
November 18, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedJune 18, 2007
June 1, 2007
November 16, 2005
June 14, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To document adverse events related to the short course of American ginseng extract, CVT-E002, in children
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CV Technologieslead
- University of Albertacollaborator
- Capital Health, Canadacollaborator
Study Sites (2)
Stollery Children's Hospital
Edmonton, Alberta, T6G 2R7, Canada
Misericordia Child Health Clinic
Edmonton, Alberta, Canada
Related Publications (1)
Vohra S, Johnston BC, Laycock KL, Midodzi WK, Dhunnoo I, Harris E, Baydala L. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics. 2008 Aug;122(2):e402-10. doi: 10.1542/peds.2007-2186.
PMID: 18676527DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunita Vohra, MD
University of Alberta/Capital Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 16, 2005
First Posted
November 18, 2005
Study Start
November 1, 2005
Study Completion
April 1, 2006
Last Updated
June 18, 2007
Record last verified: 2007-06