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| Sponsor: | Afexa Life Sciences Inc |
|---|---|
| Information provided by: | Afexa Life Sciences Inc |
| ClinicalTrials.gov Identifier: | NCT00726401 |
Purpose
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
|
| 2: Placebo Comparator |
Drug: Placebo
200mg BID for 4 weeks
|
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.
Eligibility| 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:
Contacts and Locations| Canada, Alberta | |
| Capital Health | |
| Edmonton, Alberta, Canada, T5N 4A3 | |
| Canada, Ontario | |
| McMaster University Medical Centre | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Melimar Allergy Laboratory | |
| Toronto, Ontario, Canada, M3H 3S3 | |
| JDM Research | |
| Toronto, Ontario, Canada, M4P 1P2 | |
| Principal Investigator: | Gerald Predy, FFCPC | Capital Health, Canada |
More Information
| Responsible Party: | Afexa Life Sciences ( Dr. Jacqueline Shan ) |
| Study ID Numbers: | CVT-E002-2007-2 |
| Study First Received: | July 29, 2008 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00726401 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Allergies Nasal Congestion Sneezing |
Nasal Pruritus Teary Eyes |
|
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Immune System Diseases Respiratory Tract Diseases |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Nose Diseases Respiratory Hypersensitivity |