Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- modified Rankin scale
研究概览
简要总结
The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology.
详细描述
The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology. In particular, investigators choose heat-clearing Ixeris of sonchifolia Hance(Kudiezi Injection) and blood-activating Panax notoginseng saponins(Xueshuantong Injection)as the therapeutic interventions to carry out the investigation, applying the key techniques such as Lentivirus-mediated RNA interference, co-immunoprecipitation and immunomagnetic beads.
With the joint efforts, investigators hope to find out the combined therapeutic targets based on better understanding of the inflammatory pathology in ACI and illuminate the synergistic mechanisms involved, which may validate the Chinese medicine theory of"cerebral vascular damage due to heat toxicity" in the pathogenesis of ACI and yield new therapeutic strategies for ACI. As an international science and technology cooperation project, the study is of great significance in establishing an international technology platform of intervention target system for the treatment of ACI; moreover, it marks a key step forward for China to enhance China's international brands through exploring a successful mode of foreign cooperation in Chinese medicine.
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 80 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
- •Stroke onset within 48 hours
- •NIHSS scores range from 5 points to 25 points
- •Age from forty to eighty,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),or have recieved thrombolytic therapy
- •Patients suitable for endovascular therapy,or have recieved endovascular therapy
- •Patients with serious disease of heart,lungs,liver or kidneys（The value of ALT or AST is more than 2 times of the upper limit of normal range,the value of creatinine is more than 1.5 times of the upper limit of normal range，asthma or COPD,or cardiac function level 4）
- •Patients with bleeding or bleeding tendency recently
- •Pregnant or lactating women
- •Pre-existing limb dysfunction, psychiatric diaseses，or cognitive dysfunction that could confound the study results
- •Patients with allergic constitutions,or have the contraindication of 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 basic treatment
干预措施: Ixeris of sonchifolia Hance (Drug)
Promoting blood circulaton
Treat with Xueshuantong injection on the basis of basic treatment
干预措施: Panax notoginseng saponins (Drug)
Clearing heat&Promoting blood circulaton
Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment
干预措施: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins (Drug)
结局指标
主要结局
modified Rankin scale
时间窗: 180 days
次要结局
- Barthel index(180 days)
- Glasgow coma scale(180 days)
- scores of Chinese medicine symptoms(180 days)
- national institute of health stroke scale(180 days)
- mortality rate(180 days)
- disability rate(180 days)
研究者
Yunling Zhang
President of Dongfang Hospital
Dongfang Hospital Beijing University of Chinese Medicine