Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Angong Niuhuang Pill (ANP): Angong Niuhuang Pill (ANP) (3 g/pill, 1 pill/day for 5 days)

Control (Standard treatment): Blank control

Study summary

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

Primary outcome measure(s)

• changes in the NIHSS score — after 14 days of randomization
  a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20

Trial sites (2)

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