跳至主要内容
临床试验/NCT06723366
NCT06723366尚未招募不适用

Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)

Nanjing Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
2
主要终点
changes in the NIHSS score

研究概览

简要总结

Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) an age > 18 years,
  • (2) underwent cardiovascular surgery,
  • (3) diagnosis of acute neurologic dysfunction, including but not limited acute cerebral infarction of the internal carotid artery system,
  • (4) a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20,
  • (5) a time from symptom onset to randomization within 36 h,
  • (6) provision of informed consent.

排除标准

  • (1) not suitable for taking ANP after the dialectical process by a traditional Chinese medical doctor,
  • (2) received ANP within 1 month before stroke onset,
  • (3) liver failure,
  • (4) declined to participate in this study.

研究组 & 干预措施

ANP group

Experimental

干预措施: Angong Niuhuang Pill (ANP) (Drug)

Control

Other

standard treatment

干预措施: Control (Standard treatment) (Other)

结局指标

主要结局

changes in the NIHSS score

时间窗: after 14 days of randomization

a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20

次要结局

未报告次要终点

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Liu

Principal Investigator of Department of Cardiovascular Surgery

Nanjing Medical University

研究点 (2)

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