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RECRUITING

NCT07074938

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

Sponsor: Huaqiu Zhang

View on ClinicalTrials.gov

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.

Official title: A Non-inferiority Randomized Controlled Study Comparing Jianmin Daopeng An Gong Niuhuang Wan and Tongrentang An Gong Niuhuang Wan in Promoting the Postoperative Neurological Function Recovery of Patients With Traumatic Brain Injury

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-10

Completion Date

2028-07-31

Last Updated

2025-07-20

Healthy Volunteers

Conditions

Traumatic Brain Injury

Interventions

DRUG

Jianmin Daopeng Angong Niuhuang Wan

An Gong Niu Huang Wan comes from JianMin Dapeng.

DRUG

Tongrentang Angong Niuhuang Wan

Angong Niuhuang Wan comes from Tongrentang.

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.

Locations (1)

Tongji hospital

Wuhan, Hubei, China