NCT05718908

Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement

Pilot Study of a Cohort of Patients Affected by Fibromyalgia for Symptomatic Improvement by Means of a Food Supplement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Arafarma Group, S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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®.

Detailed description

Patients who meet the fibromyalgia criteria according to the definition of the American College of Rheumatology (ACR) in 1990 and 2010, with a minimum score of 4 on the Visual Analogue Scale (VAS) of Fatigue and Pain and without any treatment (anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics) in a minimum of 4 weeks prior to the beginning of the study, with some exceptions, and who do not meet any of the exclusion criteria will be invited to participate in the study. There are three study visits which are distributed throughout 8 weeks.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food supplement	FibrofixPlus® is an authorized food supplement.

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-09-06
• Completion: 2022-11-08
• First posted: 2023-02-08
• Last updated: 2023-02-10

Locations

1 site across 1 country: Spain