NCT07495943

Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia

Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Haydarpasa Numune Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia Syndrome
• Fibromyalgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
OTHER	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.

Timeline

• Start date: 2026-05-04
• Primary completion: 2027-05-04
• Completion: 2027-05-04
• First posted: 2026-03-27
• Last updated: 2026-04-01

Locations

5 sites across 1 country: Turkey (Türkiye)