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

Official Title: “Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities”

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.

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.

Intervention(s) in this Clinical Trial

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

Primary Measures

• To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.

Secondary Measures

• To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: CV Technologies Industry

Overall Clinical Trial Officials and Contacts

Gerry Predy, MD Principal Investigator Capital Health, Canada  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259831

Study ID Number: CVT-E002-2005-3

ClinicalTrials.gov Identifier: NCT00259831

Health Authority: Canada: Health Canada