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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Jianmin Daopeng Angong Niuhuang Wan
DrugAn Gong Niu Huang Wan comes from JianMin Dapeng.
Tongrentang Angong Niuhuang Wan
DrugAngong Niuhuang Wan comes from Tongrentang.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
The changes in GCS scores before and after treatment 1 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)
Inflammatory factors: the levels of Inflammatory factors(IL-2, IL-6, WBC, neutrophils, lymphocytes, monocytes, platelets)
The levels of inflammatory factors (IL-2, IL-6, WBC, neutrophils, lymphocytes, monocytes, platelets) in brain injury patients one week and two weeks after oral administration of Jianmin Dapeng An Gong Niu Huang Wan (containing in vitro cultivated ox bile) and Tong Ren Tang An Gong Niu Huang Wan (containing natural ox bile) for treatment were compared with those before treatment.
Brain injury indicators: The levels of brain injury indicators (GFAP, NSE, S100-beta)
Brain injury indicators: The levels of brain injury indicators (GFAP, NSE, S100-beta) in patients with brain trauma after surgery, one week and two weeks after taking Jianmin Dapeng An Gong Niu Huang Pills (containing in vitro cultivated ox bile) and Tongrentang An Gong Niu Huang Pills (containing natural ox bile) were compared with those before treatment.
Imaging assessment: MRI and CT
Imaging assessment: This includes MRI and CT. Observing the recovery of the restoration of normal neural tissue structure in patients with brain trauma after one week and two weeks of oral administration of Jianmin Daopeng Anjungniuhuang Wan (containing in vitro cultivated rhinoceros horn) and Tongrentang Anjungniuhuang Wan (containing natural rhinoceros horn) treatment.
Sponsors and contacts
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Huaqiu Zhang
Lead sponsor
Tongji Hospital
Sponsor institution