Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- MRS score
研究概览
简要总结
Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis.
Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system.
The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;
- •CT examination to rule out cerebral hemorrhage;
- •With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4
排除标准
- •Diseases with bleeding tendency;
- •Liver and kidney dysfunction;
- •Malignant tumors or those undergoing anti-tumor treatment;
- •Allergic physique, allergic to aspirin or Salvianolic Acid;
- •Heart failure, multiple system failure;
- •Pregnant or breastfeeding women
研究组 & 干预措施
salvianolic acid group
salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days
干预措施: Salvianolic Acid (Drug)
0.9% NaCl
0.9%NaCl 250ml, injection, 14 days
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
MRS score
时间窗: 90 days
MRS score ≤2
次要结局
- NIHSS score(90 days)
- Cerebral blood flow volume (CBV)(90 days)
- Cerebral blood flow (CBF)(90 days)
- Adverse drug reactions (ADR)(90 days)