Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
研究概览
简要总结
The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.
详细描述
The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke
- •Patients with fire-heat syndrome
- •Stoke onset within 48 hours
- •NIHSS scores range from 5 points to 25 points
- •Age from forty to seventy-five,gender not limited
- •Informed and signed the consent
排除标准
- •Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained
- •Patients suitable for thrombolytic therapy(rt-PA, urokinase)
- •Patients have received thrombolytic therapy
- •Patients with serious diseases of heart,lungs,liver,kidneys
- •Patients with bleeding or bleeding tendency recently
- •Pregnant or lactating women
- •Pre-existing neurological or psychiatric diseases that could confound the study results
- •Patients be allergic to alcohol,Ixeris of sonchifolia Hance components (KDZ injection) or Panax notoginseng saponins components (Xueshuantong injection)
- •Patients have participated in other clinical trials within 3 months
研究组 & 干预措施
Clearing heat
Treat with KDZ injection on the basis of the basic treatment
干预措施: Ixeris of sonchifolia Hance (Drug)
Promoting blood circulation
Treat with Xueshuantong injection on the basis of the basic treatment
干预措施: Panax notoginseng saponins (Drug)
Clearing heat & Promoting blood circulation
Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment
干预措施: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins (Drug)
研究者
Yunling Zhang
President of of Dongfang Hospital
Dongfang Hospital Beijing University of Chinese Medicine