Treatment of Fibromyalgia With Recovery Factors

October 3, 2021 updated by: Practitioners Alliance Network

Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support

Treatment of Fibromyalgia and CFS with Recovery Factors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Kailua, Hawaii, United States, 96740
        • Jacob Teitelbaum MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assessing clinical outcomes
Nutritional support with Recovery Factors
Dietary supplement: Recovery Factors
A unique porcine serum based polypeptide nutritional support

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Practitioners Alliance Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 3, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN Study RF-2- 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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