Efficacy and Mechanism of Yangyin Roujin Formula in Fibromyalgia Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of the Pain VAS score from baseline.
研究概览
简要总结
This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.
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
- 是
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 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.
- •Patients who received antibiotics, probiotics, prebiotics, synbiotics, laxatives, or glucocorticoids within 3 months prior to enrollment; Patients with a history of severe gastrointestinal organic diseases, including inflammatory bowel disease, gastric ulcer, duodenal ulcer, intestinal polyposis, intestinal resection, chronic diarrhea or chronic constipation;
研究组 & 干预措施
the YangyinRoujin Decoction group
Patients in the group received YangyinRoujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
干预措施: Yangyin Roujin Decoction (Drug)
the placebo group
The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YangyinRoujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
The change of the Pain VAS score from baseline.
时间窗: Baseline, week 2, week 4, week 8, and week 12.
The 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, and week 12.)
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline(Baseline, week 2, week 4, week 8, and week 12.)
- The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.(Baseline, week 2, week 4, week 8, and week 12.)
- The change of the Beck II Depression Inventory（BDI） from baseline.(Baseline, week 2, week 4, week 8, and week 12.)
- The change of the Perceived Stress Scale (PSS) from baseline.(Baseline, week 2, week 4, week 8, and week 12.)
- The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.(Baseline, week 2, week 4, week 8, and week 12.)
- Global Impression of Change (PGIC) questionnaire evaluated at week 12.(Week 12)
- Analysis of serological indicators(0, 12 weeks)
- Gut microbiota analysis(0, 12 weeks)
- Brain imaging analysis(0, 12 weeks)
研究者
Juan Jiao
professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences