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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-07-31

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CVT E002 (Cold-fX)

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Steven Sperber, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

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Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CVT-E002-2006-1

Identifier Type: -

Identifier Source: org_study_id