A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 主要终点
- Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.
研究概览
简要总结
Research topic.
- A clinical trial of Danhong injection in treating acute ischemic stroke .
Research purpose.
- To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke by a randomized, double-blind, multi-center, placebo-controlled clinical trial.
Research design.
- A randomized, double-blind, multi-center, placebo-controlled clinical trial.
Subject crowd.
- Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and blood stasis type of traditional Chinese medicine syndrome differentiation.
Sample size. - Total sample size of 320 patients, experimental group, control group is equal to 1 to 1.
Interim analysis.
- Interim analysis will be performed when the total number of included patients up to half of the sample size ,160 cases, and according to the interim analysis results to estimate the sample size and adjust the project adaptively.
Course of treatment.
- 10 days.
Research endpoint.
- The 90th day after the medication for the first time.
Observation index.
- General condition; the physical and chemical inspection related;
- Efficacy check : mRS, BI, NIHSS;
- Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.
Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group patients of modified Rankin 0-2 grades on the 90th day.
Statistical analysis technique.
- Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral inspection, P value less than or equal to 0.05 will be considered a statistically significant difference.
详细描述
Research topic. - A clinical trial of Danhong injection in treating acute ischemic stroke .
Research purpose.
- To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke by a randomized, double-blind, multi-center, placebo-controlled clinical trial.
Research design. - A randomized, double-blind, multi-center, placebo-controlled clinical trial.
Subject crowd. - Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and blood stasis type of traditional Chinese medicine syndrome differentiation.
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, Investigator)
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
- •Accord with the diagnostic criteria of cerebral infarction of "Guide of diagnosis and treatment of acute ischemic stroke in China" in 2010, and in the acute stage;
- •Accord with the stroke and blood stasis type;
- •Onset of acute ischemic stroke within 72 hours;
- •NIHSS grade ≥ 4;
- •Age ≥ 18;
- •signed the inform consent form.
排除标准
- •Diagnosed with bleeding or other pathological brain disorders according to CT or MRI at baseline , such as vascular malformation, tumor, abscess or other common non ischemic cerebral disease (for multiple sclerosis);
- •Patients with hrombolysis or endovascular treatment;
- •Allergic constitution; the test drug allergy or its ingredients or elements allergy;
- •With severe liver function damage(ALT and AST level more than 1.5 times higher than normal);
- •With severe renal impairment (more than 1.5 times higher than normal amount of serum creatinine);
- •With severe cardiac insufficiency (cardiac function rating level III above)
- •Disabled patients of law (blind, deaf, dumb, mental retardation, mental disorder and physical disabilities caused by other reasons which affects the nerve function defect evaluation);
- •With bleeding tendency or had serious bleeding within 3 months;
- •Doubted or had alcohol and drug abuse history; Or who will lower the possibilities of enrollment or complicate the enrollment according to the investigaters' judgement;
- •Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning;
- •Who being in other clinical trials or had finished other clinical trials within 3 months.
研究组 & 干预措施
Danhong Injection
Danhong Injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days;
干预措施: Danhong Injection (Drug)
Normal Saline
0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.
时间窗: 0-90 day
Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.
次要结局
未报告次要终点