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Completed
NCT05718908
Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement
Conditions: Fibromyalgia
Sex: Female
Ages: 18 Years – N/A
Enrollment: 30
Sponsor: Arafarma Group, S.A.
Location: Spain
Summary
Fibromyalgia is a syndrome (set of symptoms) of unknown etiology and characterized by diffuse musculoskeletal pain and chronic fatigue.
In addition, other symptoms such as cognitive alterations, sleep rhythm disturbances, psychiatric syndromes such as anxiety, depression, etc.
Other very characteristic symptoms are hyperalgesia (very low pain threshold) and allodynia (amplified response to painful stimuli).The treatment of fibromyalgia is symptomatic and the drugs only serve to reduce symptoms in some patients, in addition to the fact that these available treatments (antidepressants, pain signal modulators, rescue analgesics, etc.) have many side effects.The food supplement which is the object of this study, FibrofixPlus®, is made up of a combination of natural substances.This is the reason why this observational study aims to improve symptoms caused by fibromyalgia in patients treated with FibrofixPlus®.
Eligibility Criteria
Inclusion Criteria:Women ≥ 18 years.Meet the fibromyalgia criteria according to the definition of the American College of Rheumatology of 1990 and 2010.Minimum score of 4 on the Visual Analogue Scale (VAS) for Fatigue and Pain.Period prior to the start of the study of a minimum of 4 weeks without treatment with anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics.
The use of paracetamol up to 2 g/day is allowed, and tramadol 100 mg/8h maximum.Exclusion Criteria:Current diagnosis of a psychiatric disorder other than major depressive disorder.Pain caused by a traumatic or structural injury.Chronic inflammatory diseases.Autoimmune disease.Use of medications that may interfere with the assessment of pain improvement, including analgesics (with the exception stated in the inclusion criteria), antidepressants, anticonvulsants, or other medication taken to combat fibromyalgia, fatigue or pain.Rehabilitation with therapeutic intent.Intent to apply or current disability application process.Natural therapies (homeotherapy, acupuncture, food, etc.) to improve fibromyalgia.Hypersensitivity to the active principles or to any of the excipients of the products included in the study.Pregnancy.Breastfeeding.
Source: ClinicalTrials.gov (NCT05718908). StuddyBuddy aggregates publicly available trial information.
