A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change of the Brief Pain Inventory (BPI) from baseline.
研究概览
简要总结
This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in
- •TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency.
- •aged 18 years old and above, 75 years old and below.
- •pain VAS score ≥
- •not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month.
- •Sign the informed consent.
排除标准
- •Patients with severe depression or anxiety ;
- •patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ;
- •Lactating or pregnant women ;
- •patients with allergy to therapeutic ingredients ;
- •patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ;
- •patients who have recently participated in clinical trials of the same indications ；
- •Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning.
- •Contraindications include:
- •History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc.
- •Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc.
- •Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc.
- •Claustrophobia.
结局指标
主要结局
The change of the Brief Pain Inventory (BPI) from baseline.
时间窗: Baseline, week 2, week 4, week 8, week 12 and week 24
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
次要结局
- The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- The change of the Beck II Depression Inventory（BDI） from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- The change of the Perceived Stress Scale (PSS) from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.(Baseline, week 2, week 4, week 8, week 12 and week 24)
- Global Impression of Change (PGIC) questionnaire evaluated at week 12.(Week 12.)
- Brain morphology measured by structural MRI(Before and at the end of the study ( 0, 12 weeks ).)
- Brain functional connectivity measured by function MRI(Before and at the end of the study ( 0, 12 weeks ).)
- Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids(Before and at the end of the study ( 0, 12 weeks ).)
- Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration(Before and at the end of the study ( 0, 12 weeks ).)
研究者
Juan Jiao
professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences