A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With S… (NCT00726401) | Clinical Trial Compass
CompletedPhase 2
A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Canada200 participantsStarted 2008-05
Plain-language summary
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.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion criteria
✓. Healthy individuals of both genders aged 12 - 75 years
✓. Documented clinical history of seasonal allergic rhinitis for at least 2 years with exacerbations during the study season; and exhibit a positive skin-prick test (wheal diameter at least 3 mm greater than saline control) to one of the regional allergens active during the study season
✓. Determined by the investigators that well-controlled mild to moderate asthmatics will not be excluded
✓. Daytime nasal symptoms of at least mild-to-moderate severity (cumulative score of at least 42 over a 7-day run-in period)
✓. Women of child bearing capacity who agree to use an acceptable form of birth control during the trial (i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD, or tubal ligation)
✓. Willing to adhere to the requirements of the protocol, including availability for follow-up visits
✓. Willing and able to sign written informed consent
Exclusion criteria
What they're measuring
1
Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms