Treatment of Fibromyalgia With Recovery Factors
Sponsor
Practitioners Alliance Network (Other)
Overall Status
Completed
CT.gov ID
NCT04381780
Collaborator
(none)
100
1
1
8.3
12
Study Details
Study Description
Brief Summary
Treatment of Fibromyalgia and CFS with Recovery Factors
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open pilot studyOpen pilot study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
Actual Study Start Date
:
May 6, 2020
Actual Primary Completion Date
:
Dec 1, 2020
Actual Study Completion Date
:
Jan 15, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Assessing clinical outcomes Nutritional support with Recovery Factors |
Dietary Supplement: Recovery Factors
A unique porcine serum based polypeptide nutritional support
|
Outcome Measures
Primary Outcome Measures
- Composite VAS [6 weeks]
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Secondary Outcome Measures
- FIQ-R [1 month]
Fibromyalgia Impact Questionnaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
-
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
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Practitioners Alliance Network
ClinicalTrials.gov Identifier:
NCT04381780
Other Study ID Numbers:
- PAN Study RF-2- 2020
First Posted:
May 11, 2020
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 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: