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

NCT06723366 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2024-12-12

Condition(s) studied

Cardio-pulmonary BypassCardiovascular SurgeryCerebral ProtectionBrain Injury

Investigational drug(s) / intervention(s)

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * (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. Exclusion Criteria: * (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.

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)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723366 on ClinicalTrials.gov ↗ ← All trials in China