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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CV Technologies

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)