Treatment of CFS & Fibromyalgia With Recovery Factors

Overview

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

Full Title of Study: “Treatment of CFS & Fibromyalgia With Recovery Factors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 4, 2020

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

Interventions

  • Dietary Supplement: Recovery Factors
    • Porcine serum amino acid/peptide

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Practitioners Alliance Network
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gaetano Morello, ND, Principal Investigator, Woman’s Hospital in Vancouver
  • Overall Contact(s)
    • Jacob Teitelbaum, MD, 410-573-5389, FatigueDoc@gmail.com

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