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

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

This tests whether Jianmin Daopeng Angong Niuhuang Wan (with lab-grown cow bile) helps adults who recently had a traumatic brain injury regain consciousness and neurological function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07074938 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–60 with traumatic brain injury (or within three days after related surgery), GCS 6–12, medically stable without ventilator or vasopressor support, and no contraindication to the product are the intended participants.

Not a fit: Patients outside the age range, medically unstable (requiring ventilators or vasopressors), with active intracranial infection, recent use of other arousal drugs, or contraindications to bovine/rhinoceros bile are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could provide a lower-cost, more consistent herbal option to speed recovery of consciousness and neurological function after traumatic brain injury.

How similar studies have performed: An Gong Niu Huang Wan has a long history of clinical use and some preclinical and small clinical reports suggest potential benefit for brain injury, but high-quality randomized evidence is limited.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

• Tongji hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Huaqiu Zhang — Tongji Hospital
• Study coordinator: Huaqiu Zhang

Conditions Traumatic Brain Injury