Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Hematoma volume
研究概览
简要总结
The purpose of this study is to determine whether panax notoginseng saponins are effective in the treatment of Hypertensive Intracerebral Hemorrhage Patients.
详细描述
Patients with HICH were randomly assigned to receive either PNS integrated with conventional therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14 days. Patients in the control group received conventional therapy for 17days. Hematoma volume measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel index (BI), all the three were used to evaluate the therapeutic effect for both groups after two weeks of intervention.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a history of hypertension treated with medication and blood pressure management ( a systolic blood-pressure target of 140 to 179 mmHg and a diastolic blood-pressure target of 70 to 100 mmHg) during the period of hospitalization,
- •the site of hematoma located in one of the cerebral hemispheres,
- •hematoma volume 10-30ml,
- •no blood in the ventricles,
- •within 24 hours of onset of first-time acute intracerebral hemorrhage,
- •no loss of consciousness (drowsiness acceptable).
排除标准
- •cerebellar or brainstem hemorrhage,
- •intracerebral hemorrhage caused by bleeding diathesis, aneurysms, vascular malformations, improperly using anticoagulant drugs, or suspicious amyloid angiopathy,
- •subarachnoid hemorrhage; multifocal hemorrhage,
- •mixed stroke or hemorrhagic infarct,
- •coexisting systematic diseases such as heart or kidney failure, tumors, gastrointestinal hemorrhage and so on,
- •pregnant or lactating women,
- •a history of XUESAITONG injection anaphylaxis.
研究组 & 干预措施
intervention group
Patients in the intervention group received the same conventional therapy as in the control group for 3 days, brain CT was re-scanned at the 4th day, and was then given conventional therapy plus XUESAITONG Injection,which was mainly composed of Panax notoginseng saponins for 14 days from the 4th day.
干预措施: Panax Notoginseng Saponins (Drug)
结局指标
主要结局
Hematoma volume
时间窗: within the 14 days after two weeks of intervention
Barthel index
时间窗: within the 14 days after two weeks of intervention
were measured for quality of life
National Institutes of Health Stroke Scale (NIHSS) scores
时间窗: within the 14 days after two weeks of intervention
were measured for stroke severity
次要结局
- adverse events(14 days)
研究者
Zhijian Luo
deputy chief physician, neurology physician
The First People's Hospital of Jingzhou