Traumatic Brain Injury Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tongji hospital
RECRUITING
Wuhan
Contact Information
Primary
Huaqiu Zhang
lyc@tjh.tjmu.edu.cn
+8613419632963
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Jianmin Dapeng Angong Niuhuang Wan
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.
Sham_comparator: Tongrentang Angong Niuhuang Wan
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.
Related Therapeutic Areas
Sponsors
Leads: Huaqiu Zhang

This content was sourced from clinicaltrials.gov