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

Completed · Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00435968

Run by

CV Technologies

People needed

50

Starts

2007-03-01

Expected to finish

2007-07-01

Last updated by the study team

2007-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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