Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults

CV Technologies

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Drug: CVT E002 (Cold-fX)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435968

CVT-E002-2006-1

Details and patient eligibility

About

Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX.

The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be determined through various blood tests carried out during the study.

Full description

Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to either the treatment or placebo group with equal numbers in each group.

The treatment will consist of taking three capsules of CVT-E002 (600mg) or placebo three times daily on Day 1, two capsules of CVT-E002 (400mg) or placebo three times daily on Day 2 and one capsule of CVT-E002 (200mg) or placebo three times daily on Day 3.

A fasting blood sample will be collected on all 4 days of study participation. Immunological assays and blood chemisty safety tests will be performed on the samples. Serum samples will also be collected and stored until futher analysis for various cytokines.

Any adverse events experienced during this study will be documented.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

General good health
Willing to adhere to the requirements of the protocol, including availability for follow-up visits
Willing and able to sign written informed consent

Exclusion criteria

Individuals with known HIV infection
Individuals with malignancy
Individuals with a history or symptoms of unstable cardiovascular disease
Individuals with renal abnormalities
Individuals having a history or symptoms of pulmonary disease
Individuals having acute or active chronic liver disease
Individuals having neurologic or psychiatric disease
Individuals having active tuberculosis
Individuals having multiple sclerosis
Individuals having bleeding disorders
Individuals with planned surgery over the course of the trial or having had major surgery in the past 6 mo.
Individuals with a history of alcohol/drug abuse
Pregnant and lactating women
Individuals on prescribed medication with the exception of oral contraceptives
Individuals with Crohn's disease, Lupus, Rheumatoid arthritis, Colitis or any other auto-immune disease
Individuals using natural health products or dietary supplements for 2 weeks prior and during the trial
Individuals having allergies to ginseng or to any known component of the drug product or placebo
Smokers (smoking > 10 cigarettes/day)
Alcoholics (drinking > 10 drinks/week)