Status:
COMPLETED
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
Lead Sponsor:
CV Technologies
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00435968
Start Date
March 1 2007
End Date
July 1 2007
Last Update
July 17 2007
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601