Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
研究概览
简要总结
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.
详细描述
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 100 patients (18 years ≤age ≤80 years) within 24 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 5-20 points. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase. The study consists of five visits including the day of randomization, 2-6 days, monitor daily temperature, 7 days when the therapy is done, 30 days, and 90 days when the follow-up is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The improvement of life function will be assessed by Modified Rankin Scale(namely score=0-2). The trial is anticipated to last from July 2018 to December 2019 with 100 subjects recruited form 5 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
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, Care Provider)
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
- •Acute ischemic stroke.
- •18 years ≤ age ≤ 80 years.
- •Within 24 hours from symptom onset.
- •Baseline NIHSS range 5 from
- •Provision of informed consent.
排除标准
- •Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.
- •Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- •Receive thrombolysis or endovascular treatment.
- •mRS>1 at randomization (pre-morbid historical assessment).
- •Thrombocytopenia(<100×10*9/L) , hematologic diseases and other systemic bleeding tendency.
- •Sleepy head (GCS≤7).
- •Alanine transaminase > 1.5 times normal upper limit or Aspartate aminotransferase > 1.5 times normal upper limit.
- •Glomerular filtration rate<60 ml/min/1.73m
- •Patients who have been taking AngongNiuhuang pills within 3 months.
- •Pregnancy or lactation, women in childbearing age with negative pregnancy test refuse to accept contraception.
- •Participate in clinical studies of other research drugs within the last 30 days.
- •Patients with a life expectancy of less than three months.
- •Incapable to follow this study for mental illness, cognitive or emotional disorders.
- •Unsuitable for this study in the opinion of the investigators.
研究组 & 干预措施
AngongNiuhuang
Drugs: AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke.
干预措施: AngongNiuhuang pill (Drug)
AngongNiuhuang
Drugs: AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke.
干预措施: Standard treatment (Other)
Placebo of AngongNiuhuang
Drugs: Placebo of AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke.
干预措施: Placebo of AngongNiuhuang pill (Drug)
Placebo of AngongNiuhuang
Drugs: Placebo of AngongNiuhuang pill. The other treatments will be provided according to guidelines for standard treatment of acute ischemic stroke.
干预措施: Standard treatment (Other)
结局指标
主要结局
The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
时间窗: 90days
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at the 90 days follow-up.
Severity Adverse Event
时间窗: 90days
The percentage of the Severity Adverse Events within the 90 days of the therapy.
次要结局
- Recurrent stroke, death and other vascular events(30 days, 90 days)
- The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)(7days, 30days)
- Neurological recovery(7 days, 30 days,90 days)
- Barthel Index(30 days, 90 days)
- Changes of biomarker (hs-CRP)(7 days)
- Changes of biomarker (IL-10)(7days)
- Changes of biomarker (TNF-α)(7days)
- Adverse Events(7 days, 90 days)
- Severity Adverse Event(7days)
研究者
Bin Peng
Professor
Peking Union Medical College Hospital