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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia; Fibromyalgia Syndrome
• Intervention / Treatment: Other: Placebo syrup; Dietary supplement: 2-Aticyto Complex and D-ribose Oral Supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kubra Neslihan Kurt Oktay, MD; Phone Number: +905352916609; Email: drneslihankurt@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34480
    • University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Department of Physical Medicine and Rehabilitation
    • Contact: Fatih Bagcıer, MD; Phone Number: +905442429042; Email: bagcier_42@hotmail.com
  • Istanbul, Turkey (Türkiye), 34668
    • University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Department of Physical Medicine and Rehabilitation
    • Contact: Mustafa Hüseyin Temel, MD; Phone Number: +905342714872; Email: mhuseyintemel@gmail.com
    • Sub-Investigator: Emre Ata, MD
  • Istanbul, Turkey (Türkiye), 34732
    • Erenkoy Physical Therapy and Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation
    • Contact: Sefa Kurt, MD; Phone Number: +905385159528; Email: sefa.kurt@yahoo.com
  • Istanbul, Turkey (Türkiye), 34752
    • University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Department of Physical Medicine and Rehabilitation
    • Contact: Ozge Gulsum Illeez, MD; Phone Number: +905326255684; Email: ozgeilleez@gmail.com
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34662
      • University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
      • Contact: Kubra Neslihan Kurt Oktay, MD; Phone Number: +905352916609; Email: drneslihankurt@gmail.com
      • Sub-Investigator: Arzu Erbilici, MD
      • Sub-Investigator: Duygu Geler Kulcu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)	Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neuropathic Pain Measured by DN4	Neuropathic pain symptoms will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with a total score range of 0 to 10. Higher scores indicate more neuropathic pain features, and a score of 4 or more suggests neuropathic pain. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4
Change in Fibromyalgia Impact Questionnaire Score	Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement.	Baseline, Week 2, and Week 4
Change in Fibromyalgia Participation Questionnaire Score	Fatigue severity will be assessed using the Fatigue Severity Scale, a 9-item scale with a total score range of 9 to 63. Higher scores indicate greater fatigue severity. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4
Change in Fatigue Severity Scale (FSS) Score	Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement.	Baseline, Week 2, and Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, with a global score range of 0 to 21. Higher scores indicate poorer sleep quality. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4
Change in Beck Depression Inventory Score	Depressive symptoms will be assessed using the Beck Depression Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe depressive symptoms. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4
Change in Beck Anxiety Inventory Score	Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe anxiety symptoms. Change from baseline will be compared between groups.	Baseline, Week 2, and Week 4

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital
• Collaborators: Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
• Investigators: Principal Investigator: Kubra Neslihan Kurt Oktay, MD, University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation; Study Chair: Kubra Nesihan Kurt Oktay, MD, University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Publications and helpful links

General Publications

• Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62. doi: 10.1089/acm.2006.12.857.
• Teitelbaum J, Jandrain J, McGrew R. Treatment of Chronic Fatigue Syndrome and Fibromyalgia with D-Ribose- An Open-label, Multicenter Study. The Open Pain Journal. 2012;5:32-37.
• Kerget F, Kerget B, Aksakal A, Kocak AO. Can 2-Aticyto Complex be an Effective Agent for Recovery of The Symptoms and Enhancing Laboratory Parameters in COVID-19 Patients? European Journal of Medical and Health Sciences. 2021;3(2):35-39. doi:10.24018/ejmed.2021.3.2.745.

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): May 4, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Pain; Anxiety; Double-Blind; Randomized; Sleep Quality; Fibromyalgia; Duloxetine; Pregabalin; Placebo-Controlled; Dietary Supplement; Multicenter Study; Fibromyalgia Syndrome; D-ribose; Fatique; 2-Aticyto Complex; FibroThol
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Mental Disorders; Neuromuscular Diseases; Rheumatic Diseases; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Anxiety Disorders; Fibromyalgia; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HNHAH-KAEK 2025/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Aggregate results will be reported in publications and trial registry updates.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No