Efficacy and Tolerability of CELERGEN in Fibromyalgia
Efficacy and Tolerability of CELERGEN in Fibromyalgia
NCT ID: NCT03911882 Phase: Status: COMPLETED Enrollment: 90 Completion: 2016-08-30
Conditions
Fibromyalgia
Interventions
Celergen Administration
Summary
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of marine sperm extract, hydrolyzed collagen, CoQ10, lutein and selenium. This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the: FIQ-R Fibromyalgia Impact Questionnaire Revised, Questionnaire of Health SF-12, Scale Clinical Global Impression Improvement assessed by the patient (PGI), and the Brief Pain Inventory (BPI). Blood samples were obtained at weeks 0 and 12 order for serum levels of Substance P and Tumor Necrosis Factor to measured blindly. Statistical analysis will be performed by analysis of variance for paired data.
Primary Outcome
Fibromyalgia Impact Questionnaire Revised