Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07074938

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

Led by Huaqiu Zhang · Updated on 2025-07-20

60

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with brain trauma
  • Age between 18 and 60 years inclusive
  • Within three days after injury or surgery, with stable vital signs and condition
  • Glasgow Coma Scale (GCS) score between 6 and 12, with consciousness disorder
  • No contraindications for taking artificial or natural rhinoceros bile
Not Eligible

You will not qualify if you...

  • Recent use of other awakening drugs
  • Consciousness disorders caused by traditional Chinese medicine-induced cold closure of the mind
  • Open head trauma with clear intracranial infection
  • Severe complications in other organs like pneumonia or gastrointestinal bleeding
  • History of other neurological diseases
  • Uncontrolled or unstable severe acute or chronic diseases in various systems including heart, diabetes, hypertension, blood, digestive, respiratory, autoimmune diseases
  • Liver function with ALT or AST at least 2 times upper limit, total bilirubin over 1.5 times upper limit
  • Kidney function with creatinine over 2 times upper limit
  • Abnormal coagulation function (PT or APTT prolonged over 3 seconds, platelet count below 30 x 10^9/L)
  • Pregnant or breastfeeding women
  • Unable to undergo subsequent assessments
  • Considered unsuitable by researchers to participate in the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji hospital

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

H

Huaqiu Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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