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

Official title

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

Overview

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.

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.

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.

Primary outcome measures

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

Secondary outcome measures (7)

• Change in Neuropathic Pain Measured by DN4 [Time frame: Baseline, Week 2, and Week 4]
• Change in Fibromyalgia Impact Questionnaire Score [Time frame: Baseline, Week 2, and Week 4]
• Change in Fibromyalgia Participation Questionnaire Score [Time frame: Baseline, Week 2, and Week 4]
• Change in Fatigue Severity Scale (FSS) Score [Time frame: Baseline, Week 2, and Week 4]
• Change in Pittsburgh Sleep Quality Index (PSQI) Score [Time frame: Baseline, Week 2, and Week 4]
• Change in Beck Depression Inventory Score [Time frame: Baseline, Week 2, and Week 4]
• Change in Beck Anxiety Inventory Score [Time frame: Baseline, Week 2, and Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 5 centers

• University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Departmen — Istanbul
• University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Department of Phys — Istanbul
• University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Depar — Istanbul
• Erenkoy Physical Therapy and Rehabilitation Hospital, Department of Physical Medicine and — Istanbul
• University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Departm — Istanbul

Publications

• 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.
• 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

Identifiers

NCT: NCT07495943 · HNHAH-KAEK 2025/1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗