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NCT Number: NCT06723366

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

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.

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Key information

Conditions

Cardio-pulmonary Bypass Brain Diseases Brain Injuries Brain Injury Cardiovascular Surgery Central Nervous System Diseases Cerebral Protection Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angong Niuhuang Pill (ANP)

Drug

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

Control (Standard treatment)

Other

Blank control

Primary outcomes

changes in the NIHSS score

Time frame: after 14 days of randomization

a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Yong-feng Shao, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

Beijing Anzhen Hospital
The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Dec 9, 2024
Registry last updated: Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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