Back to resultsTreatment of 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 the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS
Exclusion Criteria:
Under 18 Pregnant Other severe complicating conditions
-
Sites / Locations
- Jacob Teitelbaum MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessing clinical outcomes
Arm Description
Nutritional support with Recovery Factors
Outcomes
Primary Outcome Measures
Composite VAS
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Secondary Outcome Measures
FIQ-R
Fibromyalgia Impact Questionnaire
Full Information
NCT ID
NCT04381780
First Posted
May 6, 2020
Last Updated
October 3, 2021
Sponsor
Practitioners Alliance Network
1. Study Identification
Unique Protocol Identification Number
NCT04381780
Brief Title
Treatment of Fibromyalgia With Recovery Factors
Official Title
Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 15, 2021 (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
Treatment of Fibromyalgia and CFS with Recovery Factors
Detailed Description
Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessing clinical outcomes
Arm Type
Experimental
Arm Description
Nutritional support with Recovery Factors
Intervention Type
Dietary Supplement
Intervention Name(s)
Recovery Factors
Intervention Description
A unique porcine serum based polypeptide nutritional support
Primary Outcome Measure Information:
Title
Composite VAS
Description
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
FIQ-R
Description
Fibromyalgia Impact Questionnaire
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS
Exclusion Criteria:
Under 18 Pregnant Other severe complicating conditions
-
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 Fibromyalgia With Recovery Factors
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