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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Angong Niuhuang Pill (ANP)

    Drug

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

  • Control (Standard treatment)

    Other intervention

    Blank control

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ANP groupExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

changes in the NIHSS score

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

Time frame
after 14 days of randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Medical University

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Beijing Anzhen Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: