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

NCT05718908 | Completed

• 1 other identifier: ARA-OBS/FIB-2021-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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®.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks.

  To assess the magnitude of the symptomatic improvement by measuring the results to questions of the Fibromyalgia Impact Questionnaire (s-FIQ). This questionnaire scores from 0 to 100, being 0 the best quality of life and functional capacity, and 100 is the worst result.

  From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).

Secondary Outcomes (13)

• Rate of safety episodes.

  Visit 1 to Visit 2, up to 4 weeks.

• Change of fatigue symptom through the Visual Analogue Scale (VAS).

  From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).

• Change of fatigue symptom through the Symptom Severity Score (SS Score).

  From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).

• Change of pain symptom through the Visual Analogue Scale (VAS).

  From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).

• Change of pain symptom through the Widespread Pain Index (WPI).

  From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).

Study Arms (1)

Fibromyalgia patients

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

Dietary Supplement: Food supplement

Interventions

Food supplement DIETARY_SUPPLEMENT

FibrofixPlus® is an authorized food supplement.

Fibromyalgia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with fibromyalgia in primary care clinic.

You may qualify if:

• 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.

You may not qualify if:

• Current diagnosis of a psychiatric disorder other than major depressive disorder.
• Pain caused by a traumatic or structural injury.
• Chronic inflammatory diseases.
• Autoimmune disease.
• 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.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rodríguez Araya, Dr

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: February 8, 2023
• Study Start: March 9, 2022
• Primary Completion: September 6, 2022
• Study Completion: November 8, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

ES (1)