Jianmin Daopeng Angong Niuhuang Wan to help recovery after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults aged 18–60 with traumatic brain injury and Glasgow Coma Scale 6–12 who are within three days of injury or surgery and have stable vital signs. Participants receive one of two An Gong Niu Huang Wan formulations (Jianmin Daopeng product containing in vitro cultivated cow bile or a comparator Tongrentang formulation) alongside standard postoperative medical care. Researchers monitor neurological recovery, including consciousness level and cognitive function, through serial GCS assessments, clinical exams and imaging while tracking safety and tolerance. The study aims to determine whether the cultivated-bile formulation offers a lower-cost, more consistent option to aid postoperative neurological recovery compared with a traditional formulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with brain trauma;
2. Age range: 18 - 60 years old (inclusive of 18 and 60);
3. 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);
4. GCS score 6 - 12 points (inclusive of 6 and 12), with consciousness disorder;
5. No contraindications for taking artificial or natural rhinoceros bile.

Exclusion Criteria:

1. Have used other arousal-enhancing drugs recently;
2. Patients with consciousness disorders caused by traditional Chinese medicine-induced cold closure of the mind;
3. Patients with open head trauma who have a clear intracranial infection;
4. Patients with severe complications in other organs (such as severe pneumonia, gastrointestinal bleeding, etc.);
5. Patients who have previously suffered from other neurological diseases;
6. 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;
7. Patients who cannot undergo subsequent assessment;
8. Patients considered unsuitable to participate in the trial by the researchers.

Where it's running

• Tongji hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Huaqiu Zhang — Tongji Hospital
• Study coordinator: Huaqiu Zhang
• Email: lyc@tjh.tjmu.edu.cn
• Phone: +8613419632963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.