NCT00726401

A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Afexa Life Sciences Inc · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	COLD-fX	200mg BID for 4 weeks
DRUG	Placebo	200mg BID for 4 weeks

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-07-31
• Last updated: 2010-10-11

Locations

4 sites across 1 country: Canada