NCT01677208已完成4 期
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,503
- 试验地点
- 62
- 主要终点
- Modified Rankin Scale 0-1 (favourable outcome) at Day 90
研究概览
简要总结
The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male inpatients
- •Age: 18 - 70 years.
- •Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
- •Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke ≥
- •The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10，(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-
- •Onset of symptoms in 1 week prior to initiation of administration of study drug.
- •Clinical diagnosis of cerebral anterior circulation obstruction.
- •4≤NIHSS<
- •Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.
排除标准
- •Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.
- •Patients with thrombolysis or endovascular treatment.
- •Known history of allergy or suspected allergic to the drug.
- •Blood glucose 2.8 or > 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).
- •Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
- •Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
- •Severe cardiac dysfunction on echocardiogram or the grade of heart function over Ⅲ grade.
- •History of prior stroke with mRS ≥
- •Complicated with atrial fibrillation.
- •Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).
- •Prior disable patients.
- •Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
- •Suspected addicted into alcohol or drug abuse.
- •With severe complications that would make the condition more complicated assessed by the investigator.
- •Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
- •Woman who is under menstrual period.
- •Patient who is participating in other trials or has been participated in other trials in recent 3 months.
研究组 & 干预措施
Danhong injection
Experimental
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Danhong injection (Drug)
Danhong injection
Experimental
Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Standard medical care (Procedure)
placebo
Placebo Comparator
Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: Standard medical care (Procedure)
placebo
Placebo Comparator
Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
干预措施: placebo (Drug)
结局指标
主要结局
Modified Rankin Scale 0-1 (favourable outcome) at Day 90
时间窗: Day 90
次要结局
- Incidence of new-onset major vascular events in 90 days(Day 90)
- Barthel Index score ≥90(Day 0, Day7, Day 14, Day 30, Day 60, Day 90)
- Incidence of moderate hemorrhages in 90 days(Day 90)
- Overall mortality at day 90(Day 90)
- The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome)(Day 0, Day7, Day 14, Day 30, Day 60, Day 90)
- NIH stroke scale(NIHSS)(Day 0, Day7, Day 14, Day 30, Day 60, Day 90)
- EQ-5D scale(Day 0, Day 7, Day 14, Day 30, Day 60, Day 90)
- Global disability on mRS at Day 90.(Day 90)
- Incidence of severe hemorrhages in 90 days(Day 90)
- Documentation of adverse events (AEs) and serious AEs(90 days)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences
研究点 (62)
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