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Sponsored by: |
CV Technologies |
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Information provided by: | CV Technologies |
ClinicalTrials.gov Identifier: | NCT00726401 |
You are being asked to take part in a research study of COLD-fX, a product designed to boost the immune system. COLD-fX is an extract from the roots of North American ginseng and it may offer some benefit to people with seasonal allergies.
The purpose of the present study is to find out how effective and safe COLD-fX is in improving quality of life and reducing symptoms of seasonal allergies such as hay fever. COLD-fX is not yet approved for treatment of seasonal allergies. We are seeking to enroll 200 participants in the Capital Health region.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Drug: COLD-fX Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: COLD-fX
200mg BID for 4 weeks
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2: Placebo Comparator |
Drug: Placebo
200mg BID for 4 weeks
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A randomized, double-blind, placebo-controlled study will be carried out to establish the effects of CVT-E002 200 mg twice daily for 4 weeks in patients with seasonal allergic rhinitis.
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Medical conditions:
Medications:
Contact: Elizabeth Chomin, RN | 7809045747 | |
Contact: Lavera Sebulsky | 7804137946 |
Canada, Alberta | |
Capital Health | Recruiting |
Edmonton, Alberta, Canada, T5N 4A3 | |
Principal Investigator: Gerald Predy, FRCPC |
Principal Investigator: | Gerald Predy, FFCPC | Capital Health, Canada |
Responsible Party: | CV Technologies Inc. ( Dr. Jacqueline Shan ) |
Study ID Numbers: | CVT-E002-2007-2 |
Study First Received: | July 29, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00726401 |
Health Authority: | Canada: Health Canada |
Allergies Nasal Congestion Sneezing |
Nasal Pruritus Teary Eyes |
Pruritus Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |