Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults

NCT ID: NCT00259831

Last Updated: 2009-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-08-31

Brief Summary

The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.

Detailed Description

Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold.

Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.

Conditions

Upper Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

CVT-E002 (Cold-FX); a natural health product

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 18-64 years
• not pregnant or breast feeding
• good general health

Exclusion Criteria

• medical conditions: HIV infection; malignancy; cardiovascular disease; hypertension; renal, pulmonary or hepatic abnormalities; neurologic or psychiatric disease; tuberculosis; multiple sclerosis; recent acute respiratory infection (<2 weeks)
• medications: warfarin; immunosuppressive therapy; corticosteroids; phenalzine; pentobarbital; haloperidol
• major surgical procedure in the previous six months
• history of alcohol/drug abuse
• pregnancy and lactation in women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Capital Health, Canada

OTHER

Sponsor Role: collaborator

CV Technologies

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gerry Predy, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

The Capital Care Group Continuing Care facilities

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

CVT-E002-2005-3

Identifier Type: -

Identifier Source: org_study_id