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

NCT07074938 | Recruiting

• 1 other identifier: TJ-IRB202504084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• The changes in GCS scores before and after treatment 2 week

  We compared the improvement effects of oral administration of Jianmin Dapeng An Gong Niu Huang Wan (containing in vitro cultivated rhinoceros horn) and Tong Ren Tang An Gong Niu Huang Wan (containing natural rhinoceros horn) on the recovery of neurological function in patients with brain trauma after surgery (calculation method: compare the changes in GCS before and after treatment of the two groups, the improvement effect of neurological function = final GCS test score - GCS test score before treatment)

  2 week

Secondary Outcomes (4)

• The changes in GCS scores before and after treatment 1 week

  1 week

• Inflammatory factors: the levels of Inflammatory factors(IL-2, IL-6, WBC, neutrophils, lymphocytes, monocytes, platelets)

  1 week and 2 week

• Brain injury indicators: The levels of brain injury indicators (GFAP, NSE, S100-beta)

  1 week and 2 week

• Imaging assessment: MRI and CT

  1 week and 2 week

Study Arms (2)

Jianmin Dapeng Angong Niuhuang Wan

EXPERIMENTAL

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.

Drug: Jianmin Daopeng Angong Niuhuang Wan

Tongrentang Angong Niuhuang Wan

SHAM COMPARATOR

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.

Drug: Tongrentang Angong Niuhuang Wan

Interventions

Jianmin Daopeng Angong Niuhuang Wan DRUG

An Gong Niu Huang Wan comes from JianMin Dapeng.

Jianmin Dapeng Angong Niuhuang Wan

Tongrentang Angong Niuhuang Wan DRUG

Angong Niuhuang Wan comes from Tongrentang.

Tongrentang Angong Niuhuang Wan

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with brain trauma;
• Age range: 18 - 60 years old (inclusive of 18 and 60);
• 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);
• GCS score 6 - 12 points (inclusive of 6 and 12), with consciousness disorder;
• No contraindications for taking artificial or natural rhinoceros bile.

You may not qualify if:

• Have used other arousal-enhancing drugs recently;
• Patients with consciousness disorders caused by traditional Chinese medicine-induced cold closure of the mind;
• Patients with open head trauma who have a clear intracranial infection;
• Patients with severe complications in other organs (such as severe pneumonia, gastrointestinal bleeding, etc.);
• Patients who have previously suffered from other neurological diseases;
• 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;
• Patients who cannot undergo subsequent assessment;
• Patients considered unsuitable to participate in the trial by the researchers.

Sponsors & Collaborators

• Huaqiu Zhang: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Huaqiu Zhang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqiu Zhang

CONTACT

+8613419632963; lyc@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)