Treatment of CFS & Fibromyalgia With Recovery Factors

October 15, 2020 updated by: Practitioners Alliance Network
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum

Study Type

Interventional

Enrollment (Actual)

43

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)

Exclusion Criteria:

Pregnant Clotting disorders

-

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 efficacy
Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects
Dietary supplement: Recovery Factors
Porcine serum amino acid/peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 6 weeks
Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antibody titres
Time Frame: 10 weeks
Total IgG and IgG 1-4 subsets
10 weeks
FIQ-R
Time Frame: 6 weeks
Fibromyalgia severity scale
6 weeks

Collaborators and Investigators

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

Sponsor

Practitioners Alliance Network

Investigators

  • Principal Investigator: Gaetano Morello, ND, Woman's Hospital in Vancouver

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 20, 2019

Primary Completion (Actual)

July 4, 2020

Study Completion (Actual)

July 4, 2020

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 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN study 2019-10

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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