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Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
This study has been completed.
Study NCT00259831   Information provided by Afexa Life Sciences Inc

First Received on November 29, 2005.   Last Updated on June 4, 2009   History of Changes

November 29, 2005
June 4, 2009
December 2005
June 2006   (final data collection date for primary outcome measure)
To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.
Same as current
Complete list of historical versions of study NCT00259831 on ClinicalTrials.gov Archive Site
To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.
Same as current
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Upper Respiratory Infection
Drug: CVT-E002 (Cold-FX); a natural health product
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
August 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00259831
CVT-E002-2005-3
 
 
CV Technologies
Capital Health, Canada
Principal Investigator: Gerry Predy, MD Capital Health, Canada
Afexa Life Sciences Inc
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP