Treatment of CFS & Fibromyalgia With Recovery Factors
Not Applicable
Completed
- Conditions
- FibromyalgiaChronic Fatigue Syndrome
- Interventions
- Dietary Supplement: Recovery Factors
- Registration Number
- NCT04381793
- Lead Sponsor
- Practitioners Alliance Network
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Assessing clinical efficacy Recovery Factors 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
- Primary Outcome Measures
Name Time Method VAS 6 weeks Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
- Secondary Outcome Measures
Name Time Method antibody titres 10 weeks Total IgG and IgG 1-4 subsets
FIQ-R 6 weeks Fibromyalgia severity scale
Trial Locations
- Locations (1)
Jacob Teitelbaum MD
🇺🇸Kailua, Hawaii, United States