An Gong Niuhuang Wan Promotes the Postoperative Neurological Function Recovery of Patients With Traumatic Brain Injury

NCT ID: NCT07074938

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2028-07-31

Brief Summary

Clinical Challenges and Severity of Traumatic Brain Injury: Traumatic brain injury, as a common neurosurgical disease, poses a significant threat to patients' life safety and quality of life.The promotion of in vitro cultivated cow bile in the treatment of post-traumatic brain injury is expected to provide a more economical and effective treatment option for the recovery of consciousness and cognitive functions of TBI patients. Compared with traditional An Gong Niu Huang Wan, Jian Min Da Peng's An Gong Niu Huang Wan (containing in vitro cultivated cow bile) can not only reduce treatment costs, but also improve the stability and consistency of the quality of the drug. The above clinical research can provide scientific basis for including it in relevant treatment guidelines.

Detailed Description

Clinical Challenges and Severity of Traumatic Brain Injury: Traumatic brain injury, as a common neurosurgical disease, poses a significant threat to patients' life safety and quality of life. Post-operative patients with traumatic brain injury often suffer from severe neurological impairments, consciousness disorders, systemic inflammatory responses, and even pose a threat to their lives. The recovery of consciousness and cognitive functions is of great significance for patients' quality of life and functional rehabilitation.

Clinical Status: Currently, the treatment methods for traumatic brain injury include early emergency surgical treatment of the primary injury (such as surgical removal of intracranial hematoma, contusion and laceration of brain tissue, etc.) and post-operative drug and rehabilitation treatment for secondary neurological dysfunction (including but not limited to neurological function recovery, treatment of brain tissue edema, treatment of cerebral ischemia and its systemic inflammatory responses). For a long time, An Gong Niu Huang Wan has been used as a traditional Chinese medicine for some patients with clinical brain injury due to its significant pharmacological functions such as anti-inflammatory and clearing heat, awakening the mind and opening the orifices. However, due to the scarcity and high price of the active ingredient "natural cow bile" in An Gong Niu Huang Wan, its wide application in these patients has been limited. Jian Min Da Peng An Gong Niu Huang Wan is a kind of artificial cow bile synthesized and cultivated in the laboratory through in vitro cultivation, which has similar pharmacological properties to natural cow bile. It can not only effectively solve the problem of shortage of natural cow bile resources and high cost, but also has significant advantages in quality control.

Research Significance: The promotion of in vitro cultivated cow bile in the treatment of post-traumatic brain injury is expected to provide a more economical and effective treatment option for the recovery of consciousness and cognitive functions of TBI patients. Compared with traditional An Gong Niu Huang Wan, Jian Min Da Peng's An Gong Niu Huang Wan (containing in vitro cultivated cow bile) can not only reduce treatment costs, but also improve the stability and consistency of the quality of the drug. The above clinical research can provide scientific basis for including it in relevant treatment guidelines.

Shortcomings and Innovation Points of Existing Studies: Although An Gong Niu Huang Wan, as a traditional drug for promoting neurological function recovery, has achieved certain effects in some patients, there is a lack of standardized clinical research. The instability of treatment effects in different types of patients has led to the lack of wide recognition from clinical physicians. While in vitro cultivated cow bile is an emerging treatment method, it still lacks sufficient clinical research support. Therefore, this study fills this research gap by comparing the effect of the experimental group (Jian Min Da Peng An Gong Niu Huang Wan group) and the control group (Tong Ren Tang An Gong Niu Huang Wan group) on the recovery of neurological function in post-traumatic brain injury patients, which is highly innovative.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jianmin Dapeng Angong Niuhuang Wan

Jianmin Dapeng Angong Niuhuang Wan. All the enrolled patients were given oral medication. For those who were unable to eat independently, nasogastric administration was carried out using warm water to dissolve the medicine. Usage and dosage: Oral administration, 1 pill each time, once a day, for 1 week.

Group Type: EXPERIMENTAL

Jianmin Daopeng Angong Niuhuang Wan

Intervention Type: DRUG

An Gong Niu Huang Wan comes from JianMin Dapeng.

Tongrentang Angong Niuhuang Wan

Tongrentang Angong Niuhuang Wan. All the enrolled patients were given oral medication. For those who were unable to eat independently, nasogastric administration was carried out using warm water to dissolve the medicine. Usage and dosage: Oral administration, 1 pill each time, once a day, for 1 week.

Group Type: SHAM_COMPARATOR

Tongrentang Angong Niuhuang Wan

Intervention Type: DRUG

Angong Niuhuang Wan comes from Tongrentang.

Interventions

Jianmin Daopeng Angong Niuhuang Wan

An Gong Niu Huang Wan comes from JianMin Dapeng.

Intervention Type: DRUG

Tongrentang Angong Niuhuang Wan

Angong Niuhuang Wan comes from Tongrentang.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with brain trauma;

2. Age range: 18 - 60 years old (inclusive of 18 and 60);

3. Within three days after injury (for surgical patients, starting from the time of surgery), vital signs are stable (average arterial pressure does not continuously fall below 70 mmHg, no use of vasopressor drugs; no use of invasive or non-invasive ventilators), and the condition is stable (comparison of neurological symptoms and signs at 24-hour intervals and re-examination of CT shows no significant deterioration);

4. GCS score 6 - 12 points (inclusive of 6 and 12), with consciousness disorder;

5. No contraindications for taking artificial or natural rhinoceros bile.

Exclusion Criteria

1. Have used other arousal-enhancing drugs recently;

2. Patients with consciousness disorders caused by traditional Chinese medicine-induced cold closure of the mind;

3. Patients with open head trauma who have a clear intracranial infection;

4. Patients with severe complications in other organs (such as severe pneumonia, gastrointestinal bleeding, etc.);

5. Patients who have previously suffered from other neurological diseases;

6. Patients with severe acute or chronic diseases in various systems whose conditions have not been effectively controlled and are unstable. This includes, but is not limited to, patients with severe heart diseases such as heart function insufficiency, untreated heart failure, coronary heart disease, severe arrhythmias and other serious cardiac diseases; uncontrolled diabetes, hypertension/low blood pressure, blood system, digestive tract and respiratory system diseases, active autoimmune diseases, etc. Liver and kidney function impairment (liver function: ALT or AST ≥ 2 times the upper limit of normal, total bilirubin > 1.5 times the upper limit of normal; kidney function: Cr > 2 times the upper limit of normal); abnormal coagulation function (PT prolongation > 3 seconds, APTT prolongation > 3 seconds, platelet count < 30 x 109/L). Pregnant and lactating women;

7. Patients who cannot undergo subsequent assessment;

8. Patients considered unsuitable to participate in the trial by the researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huaqiu Zhang

OTHER

Sponsor Role: lead

Responsible Party

Huaqiu Zhang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Huaqiu Zhang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huaqiu Zhang

Role: CONTACT

lyc@tjh.tjmu.edu.cn

+8613419632963

Facility Contacts

Huaqiu Zhang, Clinical Professor

Role: primary

lyc@tjh.tjmu.edu.cn

+8613419632963

Other Identifiers

TJ-IRB202504084

Identifier Type: -

Identifier Source: org_study_id