Actively Recruiting
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
Led by Huaqiu Zhang · Updated on 2025-07-20
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Traumatic brain injury (TBI) is a common neurosurgical condition that can severely impact a patient's life and quality of life. Patients recovering from TBI often face serious neurological problems, consciousness issues, and systemic inflammatory responses. This trial studies the use of Jian Min Da Peng An Gong Niu Huang Wan, a version of a traditional Chinese medicine containing lab-grown cow bile, to support recovery of consciousness and cognitive functions after TBI. This approach aims to offer a more affordable and consistent treatment compared to traditional formulations. The trial compares two groups receiving oral medication: one group takes Jian Min Da Peng An Gong Niu Huang Wan, and the other takes Tong Ren Tang An Gong Niu Huang Wan. Both are given once daily for one week, with administration by mouth or through a feeding tube if patients cannot eat independently. This study evaluates how well the newer formulation promotes neurological recovery after surgery for traumatic brain injury, addressing previous limitations with natural cow bile supply and drug consistency. Participants will have their neurological status assessed using Glasgow Coma Scale (GCS) scores before and after treatment at one and two weeks. Inflammatory markers, brain injury indicators, and imaging with MRI and CT scans will also be monitored. The study lasts at least two weeks for primary outcome measurement, focusing on neurological function improvement, with ongoing safety assessments and comparison between the two treatment groups.
CONDITIONS
Brief Title
An Gong Niuhuang Wan Promotes the Postoperative Neurological Function Recovery of Patients With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with brain trauma
- Age between 18 and 60 years old inclusive
- Injury occurred within the past three days; for surgical patients, counted from surgery time
- Vital signs are stable without continuous low blood pressure or use of vasopressor drugs
- Neurological condition is stable with no significant deterioration on CT and symptom check
- Glasgow Coma Scale score between 6 and 12 inclusive
- No contraindications to taking artificial or natural rhinoceros bile
You will not qualify if you...
- Recent use of other arousal-enhancing drugs
- Consciousness disorders caused by traditional Chinese medicine-induced cold closure of the mind
- Open head trauma with clear intracranial infection
- Severe complications in other organs such as pneumonia or gastrointestinal bleeding
- History of other neurological diseases
- Severe acute or chronic uncontrolled diseases including serious heart conditions, uncontrolled diabetes, blood disorders, autoimmune diseases, liver or kidney impairment beyond specified limits, or abnormal coagulation
- Pregnant or breastfeeding women
- Unable to undergo subsequent assessments
- Deemed unsuitable for trial participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive either Jianmin Daopeng Angong Niuhuang Wan or Tongrentang Angong Niuhuang Wan orally once daily for 1 week to promote neurological function recovery after traumatic brain injury surgery.
Daily medication administration during treatment period
Duration - 1 week
Participants are monitored to assess neurological function recovery, inflammatory factors, brain injury indicators, and imaging results after treatment.
Assessments at 1 week and 2 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Tongji hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
H
Huaqiu Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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