Traumatic Brain InjuryNCT07074938
An Gong Niuhuang Wan Promotes the Postoperative Neurological Function Recovery of Patients With Traumatic Brain Injury
A study testing Jianmin Daopeng Angong Niuhuang Wan and Tongrentang Angong Niuhuang Wan in people with Traumatic Brain Injury, run by Huaqiu Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Jianmin Daopeng Angong Niuhuang Wan and Tongrentang Angong Niuhuang Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.);
- Patients who have previously suffered from other neurological diseases;
- 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;
- Patients who cannot undergo subsequent assessment;
- Patients considered unsuitable to participate in the trial by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 430030
Huaqiu Zhang, Clinical Professor, +8613419632963, lyc@tjh.tjmu.edu.cn
About this study
Official title: 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
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.
Read the detailed description
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. Post-operative patients with traumatic brain injury often suffer from severe neurological impairments, consciousness disorders, systemic inflammatory responses, and even pose a threat to their lives. The recovery of consciousness and cognitive functions is of great significance for patients' quality of life and functional rehabilitation.
Clinical Status: Currently, the treatment methods for traumatic brain injury include early emergency surgical treatment of the primary injury (such as surgical removal of intracranial hematoma, contusion and laceration of brain tissue, etc.) and post-operative drug and rehabilitation treatment for secondary neurological dysfunction (including but not limited to neurological function recovery, treatment of brain tissue edema, treatment of cerebral ischemia and its systemic inflammatory responses). For a long time, An Gong Niu Huang Wan has been used as a traditional Chinese medicine for some patients with clinical brain injury due to its significant pharmacological functions such as anti-inflammatory and clearing heat, awakening the mind and opening the orifices. However, due to the scarcity and high price of the active ingredient "natural cow bile" in An Gong Niu Huang Wan, its wide application in these patients has been limited. Jian Min Da Peng An Gong Niu Huang Wan is a kind of artificial cow bile synthesized and cultivated in the laboratory through in vitro cultivation, which has similar pharmacological properties to natural cow bile. It can not only effectively solve the problem of shortage of natural cow bile resources and high cost, but also has significant advantages in quality control.
Research Significance: 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.
Shortcomings and Innovation Points of Existing Studies: Although An Gong Niu Huang Wan, as a traditional drug for promoting neurological function recovery, has achieved certain effects in some patients, there is a lack of standardized clinical research. The instability of treatment effects in different types of patients has led to the lack of wide recognition from clinical physicians. While in vitro cultivated cow bile is an emerging treatment method, it still lacks sufficient clinical research support. Therefore, this study fills this research gap by comparing the effect of the experimental group (Jian Min Da Peng An Gong Niu Huang Wan group) and the control group (Tong Ren Tang An Gong Niu Huang Wan group) on the recovery of neurological function in post-traumatic brain injury patients, which is highly innovative.
- Conditions
- Traumatic Brain Injury
- Being tested
- Jianmin Daopeng Angong Niuhuang Wan, Tongrentang Angong Niuhuang Wan
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianmin Daopeng Angong Niuhuang WanDrug
An Gong Niu Huang Wan comes from JianMin Dapeng.
Tongrentang Angong Niuhuang WanDrug
Angong Niuhuang Wan comes from Tongrentang.
| Study group | Role | What they receive |
|---|---|---|
| Jianmin Dapeng Angong Niuhuang Wan | Experimental | 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. Receives: Drug: Jianmin Daopeng Angong Niuhuang Wan |
| Tongrentang Angong Niuhuang Wan | Sham comparator | 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. Receives: Drug: Tongrentang Angong Niuhuang Wan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 week
Secondary outcomes (4)
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)
Measured: 1 week
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.
Measured: 1 week and 2 week
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.
Measured: 1 week and 2 week
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.
Measured: 1 week and 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huaqiu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huaqiu Zhang, Tongji Hospital
- Investigators
- Huaqiu Zhang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074938
- Sponsor's protocol ID
- TJ-IRB202504084
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07074938
- Acronym / sponsor ID
- TJ-IRB202504084
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huaqiu ZhangUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Post-operative patients with traumatic brain injury often suffer from severe neurological impairments, consciousness disorders, systemic inflammatory responses, and even pose a threat to their lives. The recovery of consciousness and cognitive functions is of great significance for patients' quality of life and functional rehabilitation.
Clinical Status: Currently, the treatment methods for traumatic brain injury include early emergency surgical treatment of the primary injury (such as surgical removal of intracranial hematoma, contusion and laceration of brain tissue, etc.) and post-operative drug and rehabilitation treatment for secondary neurological dysfunction (including but not limited to neurological function recovery, treatment of brain tissue edema, treatment of cerebral ischemia and its systemic inflammatory responses). For a long time, An Gong Niu Huang Wan has been used as a traditional Chinese medicine for some patients with clinical brain injury due to its significant pharmacological functions such as anti-inflammatory and clearing heat, awakening the mind and opening the orifices. However, due to the scarcity and high price of the active ingredient "natural cow bile" in An Gong Niu Huang Wan, its wide application in these patients has been limited. Jian Min Da Peng An Gong Niu Huang Wan is a kind of artificial cow bile synthesized and cultivated in the laboratory through in vitro cultivation, which has similar pharmacological properties to natural cow bile. It can not only effectively solve the problem of shortage of natural cow bile resources and high cost, but also has significant advantages in quality control.
Research Significance: 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.
Shortcomings and Innovation Points of Existing Studies: Although An Gong Niu Huang Wan, as a traditional drug for promoting neurological function recovery, has achieved certain effects in some patients, there is a lack of standardized clinical research. The instability of treatment effects in different types of patients has led to the lack of wide recognition from clinical physicians. While in vitro cultivated cow bile is an emerging treatment method, it still lacks sufficient clinical research support. Therefore, this study fills this research gap by comparing the effect of the experimental group (Jian Min Da Peng An Gong Niu Huang Wan group) and the control group (Tong Ren Tang An Gong Niu Huang Wan group) on the recovery of neurological function in post-traumatic brain injury patients, which is highly innovative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jianmin Dapeng Angong Niuhuang Wan | Experimental | Drug: Jianmin Daopeng Angong Niuhuang WanJianmin 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. |
| Tongrentang Angong Niuhuang Wan | Sham comparator | Drug: Tongrentang Angong Niuhuang WanTongrentang 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.);
- Patients who have previously suffered from other neurological diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jianmin Daopeng Angong Niuhuang WanAn Gong Niu Huang Wan comes from JianMin Dapeng. | Drug | Jianmin Dapeng Angong Niuhuang Wan |
| Tongrentang Angong Niuhuang WanAngong Niuhuang Wan comes from Tongrentang. | Drug | Tongrentang Angong Niuhuang Wan |
Primary outcome
The changes in GCS scores before and after treatment 2 week
Time frame: 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)
4 secondary outcomes
The changes in GCS scores before and after treatment 1 week
Time frame: 1 week
Inflammatory factors: the levels of Inflammatory factors(IL-2, IL-6, WBC, neutrophils, lymphocytes, monocytes, platelets)
Time frame: 1 week and 2 week
Brain injury indicators: The levels of brain injury indicators (GFAP, NSE, S100-beta)
Time frame: 1 week and 2 week
Imaging assessment: MRI and CT
Time frame: 1 week and 2 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaqiu Zhang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jianmin Daopeng Angong Niuhuang Wan and Tongrentang Angong Niuhuang Wan in people with Traumatic Brain Injury, run by Huaqiu Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqiu Zhang (+8613419632963, lyc@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in GCS scores before and after treatment 2 week (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.