About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Rheumatologic disease
Renal failure
Hepatic failure
Cardiovascular disease
Trial design
Treatments tested in this trial
- 2-Aticyto Complex and D-ribose Oral Supplement
- Placebo syrup
Treatment groups
Sponsors and collaborators
Haydarpasa Numune Training and Research Hospital
Lead sponsor
Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
Collaborator