About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.);
Trial design
Treatments tested in this trial
- Jianmin Daopeng Angong Niuhuang Wan
- Tongrentang Angong Niuhuang Wan
Treatment groups
Sponsors and collaborators
Huaqiu Zhang
Lead sponsor
Tongji Hospital
Sponsor institution