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

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

July 16, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The change in innate and Th1 immune responses of the subjects

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00435968 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportions of different leukocytes and lymphocytes in blood
Intracellular and plasma concentrations of various cytokines and immunoglobulins
Incidence and severity of adverse events

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: CVT E002 (Cold-fX)

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00435968

Other Study ID Numbers ^ICMJE

CVT-E002-2006-1

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

CV Technologies

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Steven Sperber, MD

Hackensack University Medical Center

Information Provided By

Afexa Life Sciences Inc

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP