NCT04381780CompletedNot Applicable
Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
Practitioners Alliance Network2 sites in 1 country100 target enrollmentStarted: May 6, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Composite VAS
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Composite VAS
Time Frame: 6 weeks
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Secondary Outcomes
- FIQ-R(1 month)
Investigators
Study Sites (2)
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