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

CV Technologies

Status and phase

Completed

Phase 3

Conditions

Upper Respiratory Infection

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00259831

CVT-E002-2005-3

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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