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

July 16, 2007 updated by: CV Technologies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change in innate and Th1 immune responses of the subjects

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CV Technologies

Investigators

  • Principal Investigator: Steven Sperber, MD, Hackensack Meridian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 17, 2007

Last Update Submitted That Met QC Criteria

July 16, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CVT-E002-2006-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on CVT E002 (Cold-fX)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe