Clinical Trial

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

Not Yet Recruiting
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Record status
This record was last updated December 12, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-04.
Trial Details
NCT Number NCT06723366
Lead Sponsor Nanjing Medical University
Collaborators: The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital
Conditions Cardio-pulmonary Bypass, Cardiovascular Surgery, Cerebral Protection, Brain Injury
Enrollment 120 participants
Start Date 2025-01-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-12