Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angong Niuhuang Pill (ANP), Control (Standard treatment).
- Who it may be relevant to
- Registry conditions: Cardio-pulmonary Bypass, Cardiovascular Surgery, Cerebral Protection, Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery (PANDA X)
Overview
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
- Drug Angong Niuhuang Pill (ANP)
Angong Niuhuang Pill (ANP) (3 g/pill, 1 pill/day for 5 days) - Other Control (Standard treatment)
Blank control
Primary outcome measures
- changes in the NIHSS score [Time frame: after 14 days of randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Publications
- Li S, Wang A, Shi L, Liu Q, Guo X, Liu K, Wang X, Li J, Zhu J, Wu Q, Yang Q, Zhuang X, You H, Feng F, Luo Y, Li H, Ni J, Peng B. Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial. Chin Med J (Engl). 2025 Mar 5;138(5):579-588. doi: 10.1097/CM9.0000000000003133. Epub PMID 39501831
Identifiers
NCT: NCT06723366 · PANDA X