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Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

2022年2月17日 更新者:Ying Gao、Dongzhimen Hospital, Beijing

Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial

The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.

研究概览

地位

招聘中

详细说明

Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 11 days.

研究类型

介入性

注册 (预期的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国、100700
        • 招聘中
        • Dongzhimen Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of Acute ischemic stroke;
  • Symptom onset within 24 hours;
  • 35 ≤ Age ≤ 80 years;
  • 4 ≤ NIHSS ≤ 25;
  • Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Expected length of hospital stay is less than 10 days;
  • Planned or already receiving intravenous thrombolysis or endovascular treatment;
  • Use of drugs with unknown composition within 1 week before enrollment;
  • Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
  • Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
  • Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
  • Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
  • Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
  • Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
  • Other conditions that render outcomes or follow-up unlikely to be assessed;
  • Known to be pregnant or breastfeeding;
  • Currently receiving an investigational drug.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Xingnaojing injection

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Interventions:

Drug: Xingnaojing injection Other: Standard care

醒脑静注射液(20毫升)+0.9% 稀释氯化钠注射液 250ml,IV(静脉内),每 12 小时一次,持续 10 天。
无干预:Standard care

Subjects will receive guidelines-based standard care.

Interventions:

Other: Standard care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The change of NIHSS score
大体时间:Baseline, 3 days, 7 days and 10 days
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Baseline, 3 days, 7 days and 10 days

次要结果测量

结果测量
措施说明
大体时间
日常生活活动
大体时间:30天和90天
日常生活活动将在 30 天和 90 天时通过 Barthel 指数评分来衡量。Barthel 指数评分范围从 0(最差分数)到 100(最好分数)。
30天和90天
中风相关死亡和全因死亡
大体时间:10天和90天内
中风相关死亡和症状出现后 10 天内和 90 天内的任何原因死亡。
10天和90天内
安全终点
大体时间:10天
出现任何不良事件的患者人数、心电图结果、生命体征和实验室检查(全血细胞计数、化学和尿液分析)。
10天
The proportion of NIHSS score from 0 to 1
大体时间:Baseline, 3 days, 7 days and 10 days
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Baseline, 3 days, 7 days and 10 days
Patient reported outcome (PRO) scale of stroke
大体时间:10 days
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
10 days
The proportion of patients independent at 30 days and 90 days
大体时间:30 days and 90 days
The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).
30 days and 90 days
Cardio-cerebral vascular incident
大体时间:Within baseline and 90 days
Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.
Within baseline and 90 days
The difference in proteomic and metabolomics
大体时间:baseline (pre-dose), 7 days and 11days
Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.(It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.)
baseline (pre-dose), 7 days and 11days
State of consciousness
大体时间:Baseline, 3 days, 7 days and 10 days
The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Baseline, 3 days, 7 days and 10 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月28日

初级完成 (预期的)

2022年6月28日

研究完成 (预期的)

2022年9月28日

研究注册日期

首次提交

2021年3月16日

首先提交符合 QC 标准的

2021年3月21日

首次发布 (实际的)

2021年3月24日

研究记录更新

最后更新发布 (实际的)

2022年2月18日

上次提交的符合 QC 标准的更新

2022年2月17日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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