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

NCT ID: NCT06723366

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardio-pulmonary Bypass Cardiovascular Surgery Cerebral Protection Brain Injury

Keywords

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Inflammatory Response cardiopulmonary bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANP group

Group Type EXPERIMENTAL

Angong Niuhuang Pill (ANP)

Intervention Type DRUG

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

Control

standard treatment

Group Type OTHER

Control (Standard treatment)

Intervention Type OTHER

Blank control

Interventions

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Angong Niuhuang Pill (ANP)

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

Intervention Type DRUG

Control (Standard treatment)

Blank control

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator of Department of Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

Phone: 18801281613

Email: [email protected]

Yong-feng Shao, MD

Role: CONTACT

Phone: 02568303101

Email: [email protected]

Facility Contacts

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Si-chong Qian, MD

Role: primary

Hong-jia Zhang, MD

Role: backup

Hai-yang Liu, MD

Role: backup

Wei Zhang, MD

Role: primary

Hong Liu, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 39501831 (View on PubMed)

Other Identifiers

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PANDA X

Identifier Type: -

Identifier Source: org_study_id