Treatment of CFS & Fibromyalgia With Recovery Factors

The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Chronic Fatigue Syndrome
• Intervention / Treatment: Dietary supplement: Recovery Factors

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Total IgG and IgG 1-4 subsets	10 weeks
FIQ-R	Fibromyalgia severity scale	6 weeks

Collaborators and Investigators

• Sponsor: Practitioners Alliance Network
• Investigators: Principal Investigator: Gaetano Morello, ND, Woman's Hospital in Vancouver

Study record dates

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: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic
• 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