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

NCT ID: NCT05718908

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-11-08

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fibromyalgia patients

All patients will be administered with one sachet of food supplement (FibrofixPlus®) per day, for 8 weeks.

Food supplement

Intervention Type: DIETARY_SUPPLEMENT

FibrofixPlus® is an authorized food supplement.

Interventions

Food supplement

FibrofixPlus® is an authorized food supplement.

Intervention Type: DIETARY_SUPPLEMENT

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arafarma Group, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodríguez Araya, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clínic Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

ARA-OBS/FIB-2021-01

Identifier Type: -

Identifier Source: org_study_id