Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia
Starting soon · Not applicable · Has a placebo group
Conditions studied: Fibromyalgia Syndrome, Fibromyalgia
In brief
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 facts
- Study ID
- NCT07495943
- Run by
- Haydarpasa Numune Training and Research Hospital
- People needed
- 200
- Starts
- 2026-05-04
- Expected to finish
- 2027-05-04
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Able to live independently in the community
- Literate and able to record symptoms and responses
- No cognitive dysfunction that would interfere with answering study questions
- Able and willing to provide informed consent
You may not qualify if…
- Rheumatologic disease
- Renal failure
- Hepatic failure
- Cardiovascular disease
- Hypoglycemia or diabetes mellitus
- Any neurologic disease (such as stroke, spinal cord injury, multiple sclerosis, or Parkinson's disease)
- Known allergy or hypersensitivity to any active or excipient component of the study syrup
- Use of any other dietary supplement or nutritional support product during the study period
- Pregnancy or lactation
- Active malignancy
- Active infection
- Severe psychiatric disease that may interfere with study participation or assessment
- Refusal to participate or inability to provide informed consent
Where it is running
- 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)
Full record on ClinicalTrials.gov
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