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.
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
Rheumatologic disease
Renal failure
Hepatic failure
Cardiovascular disease
Parallel
2-Aticyto Complex and D-ribose Oral Supplement
Dietary supplementAn 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.
Placebo syrup
Other interventionA 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.
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
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.
Change in Neuropathic Pain Measured by DN4
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
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
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
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.
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Haydarpasa Numune Training and Research Hospital
Lead sponsor
Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
Collaborator
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