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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Medical University

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

Qualifiers

(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

Treatments tested in this trial

  • Angong Niuhuang Pill (ANP)
  • Control (Standard treatment)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Beijing Anzhen Hospital

Collaborator