Treatment of Fibromyalgia With Recovery Factors | NCT04381780

Studies
Treatment of Fibromyalgia With Recovery Factors

NCT04381780

Sponsor

Practitioners Alliance Network

Status

Completed

Last Update Posted

Oct 11, 2021Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Fibromyalgia
Chronic Fatigue Syndrome

Interventions

Recovery Factors

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

Oct 2020

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

May 6, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Jan 15, 2021Actual

First Submitted Date

May 6, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 11, 2020Actual

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

Oct 3, 2021

Last Update Posted Date

Oct 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Treatment of Fibromyalgia and CFS with Recovery Factors

Detailed Description

Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Assessing clinical outcomes	Experimental	Nutritional support with Recovery Factors	Dietary Supplement: Recovery Factors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recovery Factors	Dietary Supplement	A unique porcine serum based polypeptide nutritional support	Assessing clinical outcomes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite VAS	Composite of VAS for Fatigue, sleep, cognition, pain and overall well being	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
FIQ-R	Fibromyalgia Impact Questionnaire	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS

Exclusion Criteria:

Under 18 Pregnant Other severe complicating conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jacob Teitelbaum MD		Kailua	Hawaii	96740	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided