Clinical trial NCT05718908: Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement
Official title: Pilot Study of a Cohort of Patients Affected by Fibromyalgia for Symptomatic Improvement by Means of a Food Supplement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Lead sponsor: Arafarma Group, S.A.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with fibromyalgia in primary care clinic.

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.

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.

Primary outcomes:
measure: Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks.
timeFrame: 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:
measure: Rate of safety episodes.
timeFrame: Visit 1 to Visit 2, up to 4 weeks.
measure: Change of fatigue symptom through the Visual Analogue Scale (VAS).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of fatigue symptom through the Symptom Severity Score (SS Score).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of pain symptom through the Visual Analogue Scale (VAS).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of pain symptom through the Widespread Pain Index (WPI).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of pain symptom through the Symptom Severity Score (SS Score).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of the sleep quality through the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change of the sleep quality through the Symptom Severity Score (SS Score).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change on the functional impairment through the questionnaire Clinical Global Impressions (CGI).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change on the functional impairment through the questionnaire Short Form-36 Questionnaire (SF-36).
timeFrame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
measure: Change on the quality of life through the questionnaire Clinical Global Impressions (CGI).
timeFrame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
measure: Change on the quality of life through the questionnaire Hospital Anxiety and Depression Scale (HADS).
timeFrame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
measure: Change on the quality of life through the questionnaire Short Form-36.
timeFrame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Rodríguez Araya, Dr
role: PRINCIPAL_INVESTIGATOR
References: