Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)
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
- 否
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
干预措施: Angong Niuhuang Pill (ANP) (Drug)
Control
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
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University
