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Completed

NCT Number: NCT00435968

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CVT E002 (Cold-fX)

Drug

Primary outcomes

  1. The change in innate and Th1 immune responses of the subjects

Secondary outcomes

  1. Proportions of different leukocytes and lymphocytes in blood

  2. Intracellular and plasma concentrations of various cytokines and immunoglobulins

  3. Incidence and severity of adverse events

Sponsors and collaborators

Lead sponsor

CV Technologies

Industry

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Feb 16, 2007
Registry last updated
Jul 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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