Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo syrup (Other)
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.
干预措施: 2-Aticyto Complex and D-ribose Oral Supplement (Dietary Supplement)
结局指标
主要结局
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
时间窗: Baseline, Week 2, and Week 4
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.
次要结局
- 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)
- Change in Beck Depression Inventory Score(Baseline, Week 2, and Week 4)
- Change in Beck Anxiety Inventory Score(Baseline, Week 2, and Week 4)
研究者
Kubra Neslihan Kurt Oktay
MD
Haydarpasa Numune Training and Research Hospital