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

NCT06723366 | Not Yet Recruiting DMC

• 1 other identifier: PANDA X
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Inflammatory Response; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• changes in the NIHSS score

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

  after 14 days of randomization

Study Arms (2)

ANP group

EXPERIMENTAL

Drug: Angong Niuhuang Pill (ANP)

Control

OTHER

standard treatment

Other: Control (Standard treatment)

Interventions

Angong Niuhuang Pill (ANP) DRUG

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

ANP group

Control (Standard treatment) OTHER

Blank control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

• 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 2024 Nov 6.

  PMID: 39501831 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Angong Niuhuang Pill

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; dr.hongliu@foxmail.com

Yong-feng Shao, MD

CONTACT

02568303101; yfshaojph@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (2)