Traumatic Brain Injury
Conditions
Interventions
Routine treatment combined with rhubarb formula granules group.:Rheum palmatum formula granules intervention
Standard treatment + Placebo group:Placebo
Sponsors
Central South University Xiangya Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years (inclusive), male or female; 2. clinical diagnosis: Moderate to severe traumatic brain injury (GCS total score = 12, or GCS motor score M = 5 in intubated/tracheostomy state); 3. differential diagnosis: Real syndrome; 4. Duration of illness: 48 hours to 7 days; 5. Informed consent signed (by the subject or legal guardian). Among which: Criteria for diagnosis of moderate to severe traumatic brain injury: a. history of trauma; b. GCS score: The severity of traumatic brain injury is graded using the Glasgow Coma Scale (GCS). A total GCS score = 12 within the first 48 hours after injury defines moderate to severe traumatic brain injury. For intubated or tracheostomized subjects, a GCS motor score M = 5 is used as an equivalent criterion; c. Symptoms: Altered consciousness, possibly accompanied by seizures, limb paralysis, sensory deficits, aphasia, and hemianopia. Post-traumatic symptoms may include headache, nausea, and vomiting. Patients with skull base fractures may present with cerebrospinal fluid otorrhea or rhinorrhea. Brainstem injury may result in altered consciousness, respiratory and circulatory dysfunction, decerebrate rigidity, and severe cases may lead to brain herniation; d. Signs: Presence of obvious positive neurological signs or signs of neurological dysfunction; e. Ancillary examinations: Cranial CT/MRI findings include subdural hematoma, epidural hematoma, widespread cerebral contusion, or intracranial hematoma, etc. Criteria for diagnosis of real syndrome in traditional Chinese medicine: a. Symptoms: Fever, abdominal distension and pain on palpation, chest oppression, irritability, even loss of mental clarity and delirium, coarse breathing, copious phlegm, constipation, or diarrhea with tenesmus, dysuria, and scanty urination; b. Pulse: Forceful and full pulse; c. Tongue: Old-looking tongue with thick, greasy coating.
Exclusion criteria
Exclusion criteria: 1. Those with active bleeding, high bleeding risk, or hypotension (blood pressure below 90/60 mmHg); 2. Those with a history of severe traumatic brain injury, cerebrovascular accidents, or structural intracranial lesions; 3. Those with multiple injuries, including cervical spinal cord injuries (which may affect GOSE assessment); other severe organ injuries or serious complications that may impact the participant's life (AIS > 3 points); 4. Those with severe hepatic and renal diseases and abnormal liver and kidney function tests (ALT, AST = 3 times the upper limit of normal, Scr > 1.5 times the upper limit of normal), or those with severe cardiovascular, pulmonary, hematological, gastrointestinal diseases, or other severe or progressive systemic diseases; 5. Those with neurological or psychiatric conditions who are unable or unwilling to cooperate; 6. Pregnant, breastfeeding women, or those with recent plans for pregnancy; 7. Those with known or suspected allergies to the investigational drug or its components; 8. Those who have participated in other clinical trials and used investigational drugs within the past 3 months; 9. Those with brain herniation, GCS = 3 points, bilateral dilated and fixed pupils, and researchers anticipate imminent death or poor prognosis; 10. Those requiring continuous fasting and fluid restriction due to clinical conditions such as abdominal trauma; 11. Other factors deemed by the investigator to potentially impact the efficacy or safety evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who experienced adverse neurological outcomes (GOSE=1-4) at Day 180 of enrollment.;Protein levels of neurological injury biomarkers (S100B, UCH-L1, GFAP) in the serum of subjects on Day 0 and Day 7 of enrollment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intergroup differences in Glasgow Outcome Scale-Extended (GOSE) scores at Day 90 of enrollment.;Intergroup differences in GCS scores on day 7 and day 14;Inter-group differences in Bristol Stool Scale scoring on Day 7 and Day 14; | — |
Countries
China
Contacts
Public ContactTao Tang , Jingfang Liu
Central South University Xiangya Hospital
Outcome results
None listed