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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CVT E002 (Cold-fX)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CVT E002 (Cold-fX)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in innate and Th1 immune responses of the subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of different leukocytes and lymphocytes in blood |  |  | 
| Intracellular and plasma concentrations of various cytokines and immunoglobulins |  |  | 
| Incidence and severity of adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK Cells, Cytokines, Lymphocytes, Immunoglobulins, Th1 response