FibromyalgiaFIBROFINNCT05718908
Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement
An observational study of Fibromyalgia, run by Arafarma Group, S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Food supplement
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2022to 8 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women with fibromyalgia in primary care clinic.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of a Cohort of Patients Affected by Fibromyalgia for Symptomatic Improvement by Means of a Food Supplement
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.
Read more
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®.
Read the 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
- Being tested
- Food supplement
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
FibrofixPlus® is an authorized food supplement.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia patients | All patients will be administered with one sachet of food supplement (FibrofixPlus®) per day, for 8 weeks. Receives: Dietary Supplement: Food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
All episodes will be recorded, whether considered minor or serious, food supplement-related or not.
Measured: Visit 1 to Visit 2, up to 4 weeks.
Change of fatigue symptom through the Visual Analogue Scale (VAS).
To assess the fatigue symptom by the completion of the Visual Analogue Scale (VAS).
The VAS scores from 0 to 10, being 0 the best outcome (without fatigue) and 10 the worst outcome (maximum fatigue).
Measured: 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).
To assess the fatigue symptom by the completion of the Symptom Severity Score (SS Score).
The SS Score has a scoring from 0 to 12, being 0 the best outcome (without fatigue) and 12 the worst outcome (maximum fatigue).
Measured: 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).
To assess the pain symptom by the completion of the Visual Analogue Scale (VAS).
The VAS scores from 0 to 10, being 0 the best outcome (without fatigue) and 10 the worst outcome (maximum fatigue).
Measured: 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).
To assess the pain symptom by the completion of the Widespread Pain Index (WPI).
The WPI scores from 0 to 19, being the highest result the worst outcome as defined by the number of body areas with pain.
Measured: 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 Symptom Severity Score (SS Score).
To assess the pain symptom by the completion of the Symptom Severity Score (SS Score).
The SS Score has a scoring from 0 to 12, being 0 the best outcome and 12 the worst outcome.
Measured: 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 the sleep quality through the Pittsburgh Sleep Quality Index (PSQI).
To assess the sleep quality by the completion of the Pittsburgh Sleep Quality Index (PSQI).
The PSQI has a scoring from 0 to 21, being 0 the best outcome with no difficulties to sleep.
Measured: 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 the sleep quality through the Symptom Severity Score (SS Score).
To assess the sleep quality by the completion of the Symptom Severity Score (SS Score).
The SS Score has a scoring from 0 to 12, being 0 the best outcome and 12 the worst outcome.
Measured: 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 on the functional impairment through the questionnaire Clinical Global Impressions (CGI).
To assess the functional impairment by the completion of the Clinical Global Impressions (CGI).
The CGI has a scoring from 0 to 7, being 0 "not assessed" and 1 "normal or not ill" and 7 "extremely ill".
Measured: 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 on the functional impairment through the questionnaire Short Form-36 Questionnaire (SF-36).
To assess the functional impairment by the completion of the Short Form-36 Questionnaire (SF-36).
The SF-36 has several questions so when the scoring is higher, better is the health status. The global score is between 0 and 100, being 0 the worst and 100 the best health status.
Measured: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Change on the quality of life through the questionnaire Clinical Global Impressions (CGI).
To assess the quality of life by the completion of the questionnaire CGI. The CGI has a scoring from 0 to 7, being 0 "not assessed" and 1 "normal or not ill" and 7 "extremely ill".
Measured: 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 on the quality of life through the questionnaire Hospital Anxiety and Depression Scale (HADS).
To assess the quality of life by the completion of the HADS. The HADS has a maximum score of 21, which indicates a severe or worse status.
Measured: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Change on the quality of life through the questionnaire Short Form-36.
To assess the quality of life by the completion of the Short Form-36 Questionnaire (SF-36).
The SF-36 has several questions so when the scoring is higher, better is the health status. The global score is between 0 and 100, being 0 the worst and 100 the best health status.
Measured: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start9 Mar 2022
- Primary completion6 Sep 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodríguez Araya, Dr, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718908
- Sponsor's protocol ID
- ARA-OBS/FIB-2021-01
- Acronym
- FIBROFIN
- Status last verified
- Feb 2023
- First submitted
- 28 Nov 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Cohort of Patients Affected by Fibromyalgia for Symptomatic Improvement by Means of a Food Supplement
- ClinicalTrials.gov ID
- NCT05718908
- Acronym / sponsor ID
- FIBROFIN / ARA-OBS/FIB-2021-01
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia patients | – | Dietary Supplement: Food supplementAll patients will be administered with one sachet of food supplement (FibrofixPlus®) per day, for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with fibromyalgia in primary care clinic.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementFibrofixPlus® is an authorized food supplement. | Dietary supplement | Fibromyalgia patients |
Primary outcome
Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks.
Time frame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
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.
13 secondary outcomes
Rate of safety episodes.
Time frame: Visit 1 to Visit 2, up to 4 weeks.
Change of fatigue symptom through the Visual Analogue Scale (VAS).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 Symptom Severity Score (SS Score).
Time frame: 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 the sleep quality through the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 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 the sleep quality through the Symptom Severity Score (SS Score).
Time frame: 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 on the functional impairment through the questionnaire Clinical Global Impressions (CGI).
Time frame: 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 on the functional impairment through the questionnaire Short Form-36 Questionnaire (SF-36).
Time frame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Change on the quality of life through the questionnaire Clinical Global Impressions (CGI).
Time frame: 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 on the quality of life through the questionnaire Hospital Anxiety and Depression Scale (HADS).
Time frame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Change on the quality of life through the questionnaire Short Form-36.
Time frame: At Visit 0 and at Visit 2, or 8 weeks after Visit 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodríguez Araya, Dr principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Arafarma Group, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks. (time frame: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.