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Treatment of Fibromyalgia With Recovery Factors

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ClinicalTrials.gov Identifier: NCT04381780
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Practitioners Alliance Network

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE May 6, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
Composite VAS [ Time Frame: 1 month ]
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
FIQ-R [ Time Frame: 1 month ]
Fibromyalgia Impact Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Fibromyalgia With Recovery Factors
Official Title  ICMJE Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fibromyalgia
  • Chronic Fatigue Syndrome
Intervention  ICMJE Dietary Supplement: Recovery Factors
A unique porcine serum based polypeptide nutritional support
Study Arms  ICMJE Experimental: Assessing clinical outcomes
Nutritional support with Recovery Factors
Intervention: Dietary Supplement: Recovery Factors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jacob Teitelbaum, MD 4105627409 FatigueDoc@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04381780
Other Study ID Numbers  ICMJE PAN Study RF-2- 2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Practitioners Alliance Network
Study Sponsor  ICMJE Practitioners Alliance Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Practitioners Alliance Network
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP