NCT05933486尚未招募4 期
A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome
Quan Jiang0 个研究点目标入组 150 人开始时间: 2023年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- VAS
研究概览
简要总结
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets 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
- Quadruple (Participant, Care Provider, 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
- •Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in
- •Pain VAS score ≥ 4 points.
- •The variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks.
排除标准
- •Severe cardiovascular and cerebrovascular diseases.
- •Malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases.
- •ALT and AST are more than 2 times the upper limit of normal.
- •Cr is more than 1.2 times the upper limit of normal.
- •Allergic constitution or allergic to experimental drugs Tongluo-Kaibi tablet, pregabalin capsules, excipients or similar ingredients.
- •Pregnant, lactating or recently planned pregnancy.
研究组 & 干预措施
Tongluo-Kaibi tablet plus placebo of pregabalin
Experimental
干预措施: Tongluo-Kaibi tablet plus placebo of pregabalin (Drug)
placebo of Tongluo-Kaibi tablet plus pregabalin
Active Comparator
干预措施: placebo of Tongluo-Kaibi tablet plus pregabalin (Drug)
结局指标
主要结局
VAS
时间窗: 8 weeks
Visual Analogue Score
次要结局
- BDI(8 weeks)
- MFI-20(8 weeks)
- PSQI(8 weeks)
- WPI(8 weeks)
研究者
Quan Jiang
chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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