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Treatment of CFS & Fibromyalgia With Recovery Factors

Sponsor
Practitioners Alliance Network (Other)
Overall Status
Completed
CT.gov ID
NCT04381793
Collaborator
(none)
43
Enrollment
1
Location
1
Arm
13.5
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Recovery Factors
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open pilot study to assess efficacy and antibody effectsOpen pilot study to assess efficacy and antibody effects
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of CFS & Fibromyalgia With Recovery Factors
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
Jul 4, 2020
Actual Study Completion Date :
Jul 4, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. VAS [6 weeks]

    Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being

Secondary Outcome Measures

  1. antibody titres [10 weeks]

    Total IgG and IgG 1-4 subsets

  2. FIQ-R [6 weeks]

    Fibromyalgia severity scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jacob Teitelbaum MD Kailua Hawaii United States 96740

Sponsors and Collaborators

  • Practitioners Alliance Network

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Practitioners Alliance Network
ClinicalTrials.gov Identifier:
NCT04381793
Other Study ID Numbers:
  • PAN study 2019-10
First Posted:
May 11, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes

Study Results

No Results Posted as of Oct 19, 2020