Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259831
Status:
COMPLETED
Last Update Posted:
2009-06-08
First Post:
2005-11-29
Brief Title:
Efficacy of Cold-FX CVT-E002 in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
Sponsor:
CV Technologies
Organization:
Afexa Life Sciences Inc
Study Overview
Official Title:
Efficacy of Cold-FX CVT-E002 in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 400mgor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None