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Treatment of Fibromyalgia With Recovery Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381780
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Practitioners Alliance Network

Brief Summary:
Treatment of Fibromyalgia and CFS with Recovery Factors

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Fatigue Syndrome Dietary Supplement: Recovery Factors Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
Actual Study Start Date : May 6, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Assessing clinical outcomes
Nutritional support with Recovery Factors
Dietary Supplement: Recovery Factors
A unique porcine serum based polypeptide nutritional support




Primary Outcome Measures :
  1. Composite VAS [ Time Frame: 1 month ]
    Composite of VAS for Fatigue, sleep, cognition, pain and overall well being


Secondary Outcome Measures :
  1. FIQ-R [ Time Frame: 1 month ]
    Fibromyalgia Impact Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381780


Contacts
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Contact: Jacob Teitelbaum, MD 4105627409 FatigueDoc@gmail.com

Locations
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United States, Hawaii
Jacob Teitelbaum MD Recruiting
Kailua, Hawaii, United States, 96740
Contact: Jacob Teitelbaum    410-573-5389    FatigueDoc@gmail.com   
Sponsors and Collaborators
Practitioners Alliance Network
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Responsible Party: Practitioners Alliance Network
ClinicalTrials.gov Identifier: NCT04381780    
Other Study ID Numbers: PAN Study RF-2- 2020
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases