Back to resultsEfficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
Primary Purpose
Upper Respiratory Infection
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
CVT-E002 (Cold-FX); a natural health product
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Infection focused on measuring cold, influenza
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
Sites / Locations
- The Capital Care Group Continuing Care facilities
Outcomes
Primary Outcome Measures
To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.
Secondary Outcome Measures
To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.
Full Information
NCT ID
NCT00259831
First Posted
November 29, 2005
Last Updated
June 4, 2009
Sponsor
CV Technologies
Collaborators
Capital Health, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00259831
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CV Technologies
Collaborators
Capital Health, Canada
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infection
Keywords
cold, influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CVT-E002 (Cold-FX); a natural health product
Primary Outcome Measure Information:
Title
To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.
Secondary Outcome Measure Information:
Title
To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerry Predy, MD
Organizational Affiliation
Capital Health, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Capital Care Group Continuing Care facilities
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 2J8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
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