Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
The participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Intervention group:
300 mg ubiquinone capsule (oral) (Pharmanord, Vejle, Denmark) three times daily f
Sponsors
Andalusian Federation of Fibromyalgia and Chronic Fatigue Syndrome (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18 and 65 years old 2. Has FM according to official diagnostic criteria for FM established in 1990 by the American College of Rheumatology (ACR) 3. Duration of the illness of ten years or less
Exclusion criteria
Exclusion criteria: 1. History of renal failure (creatinine equal to or superior than 1.8 mL/dL), coronary disease in the last six months, angina, congestive heart disease, diabetes mellitus type one and two 2. Any life-threatening chronic disease (i.e., cancer disease, inflammatory bowel disease and active immune disorders) 3. Rheumatic disease (i.e., inflammatory arthritis, polymyositis, polymyalgia rheumatica) 4. Osteomalacia and osteoporosis 5. Metabolic and endocrine disease (i.e., hypothyroidism and hyperthyroidism, hyperparathyroidism, adrenal insufficiency, metabolic myopathy) 6. Infectious diseases (i.e., Epstein-Barr virus disease, brucellosis) 7. Rheumatic disease of soft tissue and myofascial pain syndrome 8. Parkinson?s disease 9. Women to become pregnant or nursing 10. Patients who are enrolled in other clinical trial or patients who participated in other clinical trial in the last 30 days 11. Any psychological or psychiatric disease to compromise the understanding of the instructions giving by the investigator 12. Any subject to be unable to follow a good complementation of the treatment 13. Any patient who denies to give the informed consent to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Coenzyme Q10 levels by High-performance liquid chromatography (HPLC) 2. Oxidative stress by spectrophotometic methods and flow cytometer 3. Inflamation parameters by Enzyme-linked immunosorbent (ELISA) assays 4. Clinical symptoms using diagnostic criteria ACR 1990, Fibromyalgia Impact Questionnaire (FIQ), Visual Analogue Scale (VAS) of pain, Beck Depression Inventory (BDI) (depression), and Pittsburgh test to determinate the quality of dream. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gene expression by Real time polymerase chain reaction (PCR) | — |
Countries
Spain
Outcome results
None listed