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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaydarpasa Numune Training and Research Hospital

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Haydarpasa Numune Training and Research Hospital

Lead sponsor

Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi

Collaborator