NCT00259831

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: CV Technologies · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	CVT-E002 (Cold-FX); a natural health product

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-06-01
• Completion: 2006-08-01
• First posted: 2005-12-01
• Last updated: 2009-06-08

Locations

1 site across 1 country: Canada