Observational Research on Use of Immunoprop Supplement in... | NCT01893619

Studies
Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome

NCT01893619

Sponsor

New York CFS Association

Status

Unknown status

Last Update Posted

Jul 25, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Fatigue Syndrome

Interventions

Not provided

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jul 2, 2013

First Submission Date that Met QC Criteria

Jul 8, 2013

First Posted Date

Jul 9, 2013Estimated

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 24, 2013

Last Update Posted Date

Jul 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observational study regarding the use of supplements in chronic fatigue syndrome patients

Detailed Description

Detailed questionnaire regarding the diagnosis of an onset of chronic fatigue syndrome and 100 patients. using Karnofsky scale before and after use of supplements patient scores are compared in a double blind trial.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Karnovsky score comparison	Review of Karnofsky score over prior to diagnosis and subsequent to patients having taken supplements	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection

Exclusion Criteria:

non inclusion in the above criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DEREK enlander	CFIDS RESEARCH FOUNDATION	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Me/Cfs Center,860 Fifth Avenue	Recruiting	New York	New York	10065	United States

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

Not provided

Browse Branches

Not provided