Back to resultsTreatment of CFS & Fibromyalgia With Recovery Factors
Primary Purpose
Fibromyalgia, Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Factors
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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
-
Sites / Locations
- Jacob Teitelbaum MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessing clinical efficacy
Arm 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. 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
Outcomes
Primary Outcome Measures
VAS
Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
Secondary Outcome Measures
antibody titres
Total IgG and IgG 1-4 subsets
FIQ-R
Fibromyalgia severity scale
Full Information
NCT ID
NCT04381793
First Posted
May 6, 2020
Last Updated
October 15, 2020
Sponsor
Practitioners Alliance Network
1. Study Identification
Unique Protocol Identification Number
NCT04381793
Brief Title
Treatment of CFS & Fibromyalgia With Recovery Factors
Official Title
Treatment of CFS & Fibromyalgia With Recovery Factors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
July 4, 2020 (Actual)
Study Completion Date
July 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Practitioners Alliance Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open pilot study to assess efficacy and antibody effects
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessing clinical efficacy
Arm Type
Experimental
Arm 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. 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Recovery Factors
Intervention Description
Porcine serum amino acid/peptide
Primary Outcome Measure Information:
Title
VAS
Description
Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
antibody titres
Description
Total IgG and IgG 1-4 subsets
Time Frame
10 weeks
Title
FIQ-R
Description
Fibromyalgia severity scale
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Morello, ND
Organizational Affiliation
Woman's Hospital in Vancouver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacob Teitelbaum MD
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96740
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of CFS & Fibromyalgia With Recovery Factors
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