Upper Respiratory Infection Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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