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

NCT00726401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-10-11

No results posted yet for this study

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.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

COLD-fX

200mg BID for 4 weeks

DRUG

Placebo

200mg BID for 4 weeks

Sponsors & Collaborators

  • Afexa Life Sciences Inc

    lead INDUSTRY

Principal Investigators

  • Gerald Predy, FFCPC · Capital Health, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00726401 on ClinicalTrials.gov