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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259831

Enrollment

500

Registered

2005-12-01

Start date

2005-12-31

Completion date

2006-08-31

Last updated

2009-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Infection

Keywords

cold, influenza

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.

Interventions

DRUGCVT-E002 (Cold-FX); a natural health product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.	—

Secondary

Measure	Time frame
To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026