Safety and Immune Enhancing Effects of Acute Dosing of CO... | NCT00435968

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

NCT00435968

Sponsor

CV Technologies

Status

Completed

Last Update Posted

Jul 17, 2007Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Healthy

Interventions

CVT E002 (Cold-fX)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Feb 14, 2007

First Submission Date that Met QC Criteria

Feb 15, 2007

First Posted Date

Feb 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2007

Last Update Posted Date

Jul 17, 2007Estimated

Description Module

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 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
CVT E002 (Cold-fX)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in innate and Th1 immune responses of the subjects

Secondary Outcomes

Measure	Description	Time Frame
Proportions of different leukocytes and lymphocytes in blood
Intracellular and plasma concentrations of various cytokines and immunoglobulins
Incidence and severity of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided