About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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,
Disqualifiers
(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.
Trial design
Parallel
Treatments tested in this trial
Angong Niuhuang Pill (ANP)
DrugAngong Niuhuang Pill (ANP) (3 g/pill, 1 pill/day for 5 days)
Control (Standard treatment)
Other interventionBlank control
Treatment groups
Trial outcomes
Primary outcomes
changes in the NIHSS score
a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20
Sponsors and contacts
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Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Beijing Anzhen Hospital
Collaborator
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