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

NCT07495943 | Not Yet Recruiting

• 1 other identifier: HNHAH-KAEK 2025/1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Fibromyalgia; Fibromyalgia Syndrome; 2-Aticyto Complex; D-ribose; FibroThol; Dietary Supplement; Placebo-Controlled; Randomized; Double-Blind; Multicenter Study; Pregabalin; Duloxetine; Pain; Fatique; Sleep Quality; Depression; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Neuropathic Pain Measured by DN4

  Baseline, Week 2, and Week 4

• Change in Fibromyalgia Impact Questionnaire Score

  Baseline, Week 2, and Week 4

• Change in Fibromyalgia Participation Questionnaire Score

  Baseline, Week 2, and Week 4

• Change in Fatigue Severity Scale (FSS) Score

  Baseline, Week 2, and Week 4

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Week 2, and Week 4

Study Arms (2)

Placebo Plus Standard Treatment

PLACEBO COMPARATOR

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

FibroThol Plus Standard Treatment

EXPERIMENTAL

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

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.

FibroThol Plus Standard Treatment

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.

Placebo Plus Standard Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead
• Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi: collaborator

Study Sites (5)

University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, Istanbul, 34662, Turkey (Türkiye)

Location

University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34480, Turkey (Türkiye)

Location

University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34668, Turkey (Türkiye)

Location

Erenkoy Physical Therapy and Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34732, Turkey (Türkiye)

Location

University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17109576 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain; Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kubra Neslihan Kurt Oktay, MD

  University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Kubra Nesihan Kurt Oktay, MD

  University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation

  STUDY CHAIR

Central Study Contacts

Kubra Neslihan Kurt Oktay, MD

CONTACT

+905352916609; drneslihankurt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will remain blinded to treatment assignment throughout the study. Active treatment and placebo will be provided in similar packaging and appearance to preserve blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be assigned by block randomization in a 1:1 ratio to one of two parallel groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. Study treatment will be administered orally for 4 weeks in a multicenter setting.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): May 4, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5)