Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cerebral edema volume
研究概览
简要总结
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce 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 difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.
详细描述
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial. Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1pill qd/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1pill qd/day for 5-day. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline. The study was consisted of six visits, including the day of randomization, 2 days, 3-6 days, 7 days (the endap time of the therapy), 14 days, and 90 days (the endap time of the follow-up). Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The period of the trial is from August 2020 to October 2021, and 120 subjects are planned to be recruited from 10 centers in China. All the related investigative organizations and individuals will obey the Declaration of Helsinki and Chinese Guard-cell protoplast (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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participates aged 40-80 years.
- •Diagnosis with acute ischemic stroke.
- •Diagnosis with acute cerebral infarctions of internal carotid artery system.
- •10≤ Baseline NIHSS <
- •Time of onset ≤36h.
- •Provision of informed consent.
排除标准
- •Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.
- •Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- •Patients with hemorrhagic transformation after cerebral infarction.
- •Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.
- •Received or planned to receive decompression craniectomy.
- •With mRS score >1 before onset of this episode.
- •Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.
- •With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleeding tendency.
- •With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upper limit or Creatinine >1.5 times than normal upper limit.
- •Allergic to ingredients of AngongNiuhuang pill.
- •Received AngongNiuhuang pill within 1 month.
- •Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.
- •Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.
- •Participates with a life expectancy less than 3 months.
- •Incapable to follow this study due to mental illness, cognitive or emotional disorders.
- •Participates are not eligible for this clinical trial as evaluated by the investigators.
研究组 & 干预措施
AngongNiuhuang
Drugs : AngongNiuhuang pill. The other treatments will 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 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 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 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
Cerebral edema volume
时间窗: 14 days
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
Cerebral infarction volume
时间窗: 14 days
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
时间窗: 90 days
Severity Adverse Events
次要结局
- Cerebral edema volume(90 days)
- Changes of biomarker (MMP-9)(7 days)
- Cerebral infarction volume(90 days)
- Changes of biomarker (hs-CRP)(7 days)
- The proportion of the patients with Severity Adverse Events within 7 days of the treatment.(7 days)
- Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.(7 days, 14 days)
- Changes of biomarker (NSE)(7 days)
- Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.(14 days, 90 days)
- Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.(7 days)
- The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.(7 days, 90 days)
- The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.(14 days, 90 days)
- The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.(7 days, 90 days)
- Changes of biomarker (S-100B)(7 days)
- The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.(7 days, 90 days)
研究者
Bin Peng
Professor
Peking Union Medical College Hospital