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CompletedNCT00435968Updated Jul 17, 2007

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

A Phase 2 interventional study of CVT E002 (Cold-fX) in Healthy, sponsored by CV Technologies. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-17.

Sponsored by CV Technologies · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • NK Cells
  • Cytokines
  • Lymphocytes
  • Immunoglobulins
  • Th1 response
03

In context

Lead sponsor

CV Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants (estimated)

Interventions

  • DrugCVT E002 (Cold-fX)
06

What researchers measure

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

07

Study locations

1 site
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00435968
Lead sponsor
CV Technologies
First posted
Feb 16, 2007
Start date
Mar 2007
Completion
Jul 2007
Last update
Jul 17, 2007

Study contacts

Steven Sperber, MD
principal investigator · Hackensack Meridian Health
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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