The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual analogue scale pain scores
研究概览
简要总结
Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-70 years old.
- •patients who meet the diagnostic criteria of American College of Rheumatology in
- •patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
- •pain scores between3 and 7 on visual analogue scale.
- •patients sign the informed consent forms.
排除标准
- •pregnant and lactating women.
- •patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
- •patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
- •patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
- •patients with severe pain resulted from diabetic and postherpetic neuralgia.
- •patients who are allergic to the drugs used in this study.
- •patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.
研究组 & 干预措施
Shugan Dingtong decoction
Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
干预措施: Shugan Dingtong decoction (Drug)
duloxetine hydrochloride
Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
干预措施: Duloxetine Hydrochloride (Drug)
结局指标
主要结局
Visual analogue scale pain scores
时间窗: 12 Weeks
The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain.
次要结局
- Fibromyalgia impact questionnaire(12 Weeks)
- Fatigue scale-14(12 Weeks)
- Pittsburgh sleep quality index(12 Weeks)
- Traditional Chinses medicine symptom score(12 Weeks)
研究者
Yuan Xu
professor
China-Japan Friendship Hospital