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

Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06723366
Enrollment
120
Registered
2024-12-09
Start date
2025-01-01
Completion date
2025-12-31
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Cardio-pulmonary Bypass, Cardiovascular Surgery, Cerebral Protection

Keywords

Inflammatory Response, cardiopulmonary bypass

Brief 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.

Interventions

DRUGAngong Niuhuang Pill (ANP)

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

OTHERControl (Standard treatment)

Blank control

Sponsors

The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Beijing Anzhen Hospital
CollaboratorOTHER
Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
changes in the NIHSS scoreafter 14 days of randomizationa National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20

Countries

China

Contacts

Primary ContactHong Liu, MD
dr.hongliu@foxmail.com18801281613
Backup ContactYong-feng Shao, MD
yfshaojph@sina.com02568303101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026