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Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
This study has been completed.
Sponsored by: CV Technologies
Information provided by: CV Technologies
ClinicalTrials.gov Identifier: NCT00435968
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: CVT E002 (Cold-fX)
 Phase II

Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults

Further study details as provided by CV Technologies:

Primary Outcome Measures:
  • The change in innate and Th1 immune responses of the subjects

Secondary Outcome Measures:
  • Proportions of different leukocytes and lymphocytes in blood
  • Intracellular and plasma concentrations of various cytokines and immunoglobulins
  • Incidence and severity of adverse events

Estimated Enrollment: 50
Study Start Date: March 2007
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435968

Locations
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
CV Technologies
Investigators
Principal Investigator: Steven Sperber, MD Hackensack University Medical Center
  More Information

Study ID Numbers: CVT-E002-2006-1
Study First Received: February 14, 2007
Last Updated: July 16, 2007
ClinicalTrials.gov Identifier: NCT00435968  
Health Authority: United States: Institutional Review Board

Keywords provided by CV Technologies:
NK Cells
Cytokines
Lymphocytes
Immunoglobulins
Th1 response

Study placed in the following topic categories:
Antibodies
Healthy
Immunoglobulins

ClinicalTrials.gov processed this record on January 13, 2009



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