Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke
试验速览
- 阶段
- 4 期
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- self-care
研究概览
简要总结
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage
详细描述
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① It meets the diagnostic criteria of primary cerebral hemorrhage.
- •Within 72 hours of onset.
- •National Institutes of Health Stroke Scale (NIHSS) score ≥4 points.
- •④ Glasgow Coma Scale (GCS) score > Eight points.
- •Patient or legal representative informed consent, and sign informed consent.
排除标准
- •(1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic.
- •The patients with previous stroke history and remaining sequelae affected the outcome assessment, that is, the modified Ranking scale (MRS) score before the onset of stroke was ≥2 points.
- •(3) known by amyloid cerebrovascular disease, vascular malformation, aneurysm, blood coagulation dysfunction, anticoagulation and antiplatelet drug treatment, thrombolysis therapy, bleeding after infarction after conversion, haematology, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, and vascular inflammation caused by clear etiology of patients with cerebral hemorrhage or primary intraventricular hemorrhage.
- •(Note: "After anticoagulant or antiplatelet therapy" refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
研究组 & 干预措施
Xingnaojing injection + Shuxuetong oral liquid
Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
干预措施: Xingnaojing injection + Shuxuetong oral liquid (Drug)
Placebo group
Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.
干预措施: Xingnaojing injection + Shuxuetong oral liquid (Drug)
结局指标
主要结局
self-care
时间窗: after 90 days
90 days of self-care (mRS 0-2 points)
次要结局
- NIHSS(on day 14 of onset)