NCT06344312进行中（未招募）不适用
Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction: a Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
研究概览
简要总结
Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years old, regardless of gender
- •After the onset of this disease, the National Institutes of Research Stroke Scale score was 2 ≤ NIHSS ≤ 20 points
- •Patients who have developed symptoms within 4.5 hours and can receive rt PA intravenous thrombolysis treatment
- •According to the 2019 Diagnosis Points for Major Cerebrovascular Diseases in China, patients with ischemic stroke were diagnosed as having a good recovery from the first or last onset (mRS score ≤ 1 point before this onset)
- •Obtain the patient or their legal representative to voluntarily sign an informed consent form approved by the ethics committee.
排除标准
- •Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment
- •Severe consciousness disorder: NIHSS scored>1 point in the 1a consciousness level item
- •After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 180mmHg or the diastolic blood pressure remains ≥ 100mmHg
- •Blood glucose<2.8mmol/L (random blood glucose measurement device can be used)
- •Patients with severe mental disorders and dementia
- •Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST>2.0 x ULN
- •Diagnosed with severe active kidney disease and renal insufficiency; Or serum creatinine>1.5 × ULN
- •Concurrent malignant tumors or ongoing anti-tumor treatment; For subjects diagnosed with malignant tumors after enrollment, the decision to continue participating in the study can be based on the researcher's judgment and the subject's willingness
- •Suffering from severe systemic diseases, with an estimated survival time of<90 days
- •History of major surgery within 4 weeks prior to enrollment
- •Participated in other clinical studies within the first 30 days of randomization, or is currently participating in other clinical studies
- •The researcher believes that it is not suitable to participate in this clinical study
- •Patients who are allergic to any ingredient in the study drug
研究组 & 干预措施
Experimental group
Experimental
Randomly take 2 bags of Yangxue Qingnao Granules orally during intravenous thrombolysis with ateplase, and then take 1 bag of Yangxue Qingnao Granules three times a day for a total of 2 weeks
干预措施: Yangxue Qingnao Granules (Drug)
Control Group
Placebo Comparator
When receiving intravenous thrombolysis with ateplase, two bags of Yangxue Qingnao Granule Simulator were randomly taken orally. Afterwards, one bag of Yangxue Qingnao Granule Simulator was taken three times a day for a total of two weeks.
干预措施: Yangxue Qingnao Granules (Drug)
结局指标
主要结局
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment
时间窗: 90 days
次要结局
未报告次要终点
研究者
研究点 (1)
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