Fibromyalgia Syndrome, Fibromyalgia
Conditions
Keywords
Fibromyalgia, Fibromyalgia Syndrome, 2-Aticyto Complex, D-ribose, FibroThol, Dietary Supplement, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, Pregabalin, Duloxetine, Pain, Fatique, Sleep Quality, Depression, Anxiety, Quality of Life
Brief summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Eligible participants are adults aged 18 to 65 years who have had fibromyalgia for at least 1 year and have been receiving pregabalin and/or duloxetine for at least 3 months. Participants will be randomly assigned to receive either FibroThol or placebo, administered as 15 mL three times daily for 4 weeks, while continuing their existing treatment. Follow-up assessments will be performed at baseline, week 2, and week 4 using patient-reported symptom and function measures. The study aims to determine whether this supportive supplement provides additional benefit compared with placebo in patients with persistent symptoms despite standard therapy.
Detailed description
Fibromyalgia syndrome is a chronic condition associated with widespread pain, fatigue, sleep disturbance, and reduced quality of life. Although standard pharmacologic treatments such as pregabalin and duloxetine are commonly used, symptom control may remain incomplete in many patients. This study was designed to investigate whether adding a supplement containing 2-Aticyto Complex and D-ribose to ongoing standard treatment can improve clinical outcomes in adults with fibromyalgia syndrome. This is a multicenter, randomized, double-blind, placebo-controlled clinical study. Adults aged 18 to 65 years with fibromyalgia syndrome, diagnosed according to the ACR 2016 criteria, followed for at least 1 year, and receiving pregabalin and/or duloxetine treatment for at least 3 months will be eligible for participation. Major exclusion criteria include rheumatologic disease, renal failure, hepatic failure, cardiovascular disease, diabetes or hypoglycemia, neurologic disease, use of other supplements, allergy to study product ingredients, inability to complete study procedures, or refusal to participate. After eligibility assessment and informed consent, participants will be randomly assigned to one of two study groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. The study treatment will be administered orally at a dose of 15 mL three times daily for 4 weeks. Study visits and assessments will be performed at baseline, week 2, and week 4. Outcome measures will include pain intensity, neuropathic pain, fibromyalgia-related functional status, fatigue, sleep quality, anxiety, and depression, assessed using validated clinical scales. Safety will be evaluated through adverse event monitoring during the study period. A total of 200 participants will be enrolled, with 100 participants assigned to the FibroThol group and 100 participants assigned to the placebo group. The primary objective is to determine whether the addition of 2-Aticyto Complex and D-ribose to standard treatment provides additional benefit in reducing pain and improving symptoms and overall clinical course in patients with fibromyalgia syndrome.
Interventions
DIETARY_SUPPLEMENT2-Aticyto Complex and D-ribose Oral Supplement
An oral dietary supplement containing 2-Aticyto Complex and D-ribose (marketed as FibroThol). In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine.
OTHERPlacebo syrup
A matching oral placebo syrup without active study ingredients. In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine. The placebo contains deionized water, glycerol, sodium alginate, xanthan gum, steviol glycosides, raspberry flavor, pineapple flavor, strawberry flavor, and mint flavor.
Sponsors
Haydarpasa Numune Training and Research Hospital
Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators will remain blinded to treatment assignment throughout the study. Active treatment and placebo will be provided in similar packaging and appearance to preserve blinding.
Intervention model description
Participants will be assigned by block randomization in a 1:1 ratio to one of two parallel groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. Study treatment will be administered orally for 4 weeks in a multicenter setting.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years * Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria * Followed in a physical medicine and rehabilitation outpatient clinic for at least 1 year * Receiving pregabalin and/or duloxetine treatment for at least 3 months * Able to live independently in the community * Literate and able to record symptoms and responses * No cognitive dysfunction that would interfere with answering study questions * Able and willing to provide informed consent
Exclusion criteria
* Rheumatologic disease * Renal failure * Hepatic failure * Cardiovascular disease * Hypoglycemia or diabetes mellitus * Any neurologic disease (such as stroke, spinal cord injury, multiple sclerosis, or Parkinson's disease) * Known allergy or hypersensitivity to any active or excipient component of the study syrup * Use of any other dietary supplement or nutritional support product during the study period * Pregnancy or lactation * Active malignancy * Active infection * Severe psychiatric disease that may interfere with study participation or assessment * Refusal to participate or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Numeric Rating Scale (NRS) | Baseline, Week 2, and Week 4 | Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. Change from baseline will be compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain Measured by DN4 | Baseline, Week 2, and Week 4 | Neuropathic pain symptoms will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with a total score range of 0 to 10. Higher scores indicate more neuropathic pain features, and a score of 4 or more suggests neuropathic pain. Change from baseline will be compared between groups. |
| Change in Fibromyalgia Impact Questionnaire Score | Baseline, Week 2, and Week 4 | Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement. |
| Change in Fibromyalgia Participation Questionnaire Score | Baseline, Week 2, and Week 4 | Fatigue severity will be assessed using the Fatigue Severity Scale, a 9-item scale with a total score range of 9 to 63. Higher scores indicate greater fatigue severity. Change from baseline will be compared between groups. |
| Change in Fatigue Severity Scale (FSS) Score | Baseline, Week 2, and Week 4 | Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline, Week 2, and Week 4 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, with a global score range of 0 to 21. Higher scores indicate poorer sleep quality. Change from baseline will be compared between groups. |
| Change in Beck Depression Inventory Score | Baseline, Week 2, and Week 4 | Depressive symptoms will be assessed using the Beck Depression Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe depressive symptoms. Change from baseline will be compared between groups. |
| Change in Beck Anxiety Inventory Score | Baseline, Week 2, and Week 4 | Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe anxiety symptoms. Change from baseline will be compared between groups. |
Countries
Turkey (Türkiye)
Contacts
CONTACTKubra Neslihan Kurt Oktay, MD
PRINCIPAL_INVESTIGATORKubra Neslihan Kurt Oktay, MD
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
STUDY_CHAIRKubra Nesihan Kurt Oktay, MD
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Outcome results
None listed