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

Sponsor
Haydarpasa Numune Training and Research Hospital
Study ID
NCT07495943
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Fibromyalgia
  • Fibromyalgia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 2-Aticyto Complex and D-ribose Oral Supplement — DIETARY_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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Mar 27, 2026
Start date
May 4, 2026
Status verified
Mar 2026
Primary completion
May 4, 2027
Completion
May 4, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Plus Standard Treatment
    Participants will receive matching placebo orally at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine.
  • Experimental: FibroThol Plus Standard Treatment
    Participants will receive FibroThol, an oral supplement containing 2-Aticyto Complex and D-ribose, at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine.

Primary Outcome Measure

Change in Pain Intensity Measured by Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 2, and Week 4 ]

Central Contacts

Related Studies