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

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.

Conditions

• Fibromyalgia Syndrome
• Fibromyalgia

Interventions

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.

Sponsors & Collaborators

• Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi

  collaborator INDUSTRY

• Haydarpasa Numune Training and Research Hospital

  lead OTHER

Principal Investigators

• Kubra Neslihan Kurt Oktay, MD · University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

• Kubra Nesihan Kurt Oktay, MD · University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-04

Primary Completion

2027-05-04

Completion

2027-05-04

Countries

• Turkey (Türkiye)

Study Locations