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Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia
Sponsor: Haydarpasa Numune Training and Research Hospital
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.
Official title: Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-05-04
Completion Date
2027-05-04
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
2-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.
Placebo 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.
Locations (5)
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Istanbul, Turkey (Türkiye)
University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
Erenkoy Physical Therapy and Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)