A multi-center, randomized, double-blind, placebo-controlled clinical study of SXHYXN combined with ZLHXTY in the treatment of cerebral hemorrhage
- Conditions
- Cerebral hemorrhage
- Registration Number
- ITMCTR2000004075
- Lead Sponsor
- Hospital of Traditional Chinese Medicine affiliated to Southwest Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019;
2. Patients with age of onset greater than or equal to 18 years and less than or equal to 80 years; Onset is less than or equal to 72 hours;
3. In patients with cerebral hemorrhage, the bleeding site is in the basal ganglia region or thalamus (if the haematoma is accompanied by the entry into the ventricular system, it is limited to the condition that no ventricular cast or obstructive hydrocephalus is formed);
4. The bleeding volume is less than or equal to 30ml;
5. NIHSS score is less than or equal to 36 points;
6. The patient and/or the client authorized by the patient give informed consent and sign the informed consent.
1. Cerebral hemorrhage caused by trauma, medication, tumor, vascular malformation, aneurysm rupture, etc.;
2. Multiple focal cerebral hemorrhage (refers to more than or equal to two bleeding sites, or combined with subarachnoid hemorrhage, acute subdural hemorrhage, acute epidural blood); Combined with acute cerebral infarction
3. Patients who have previously suffered from apoplexy and have sequelae leading to disability (mRS>=grade 3);
4. Severe brain swelling, midline shift of the brain greater than or equal to 5mm; Or hydrocephalus caused by the outflow of cerebrospinal fluid;
5. Patients who had developed serious digestive tract diseases (such as intestinal adhesion, intestinal obstruction, intestinal tumor, etc.) in the last 3 months before the study or had active gastrointestinal bleeding in the last 1 month or needed to fast for some reasons;
6. Patients with venous system thrombosis, heart valve disease, etc., who need anticoagulant therapy and antiplatelet aggregation therapy;
7. Known liver injury or potentially severe liver disease (ALT or AST > 10 times normal);
8. Patients with known severe renal impairment (eGFR<25mL/min/1.73?); Or intends to undergo/is undergoing dialysis treatment; Or acute angiographic agent nephropathy was found at the time of screening;
9. Patients with blood system diseases or other diseases resulting in coagulation dysfunction;
10. Women who are pregnant or breastfeeding;
11. Patients with drug allergy or intolerance in this study;
12. Patients who have participated in other clinical trials;
13. Patients cannot cooperate with examination and treatment;
14. Patients or their family members refused to participate in the study;
15. The researchers considered that the patients who were included in this study were not suitable;
16. Patients with malignant neoplasms or other diseases and with a life expectancy of less than one year.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intracranial hematoma volume;Intracranial edema;
- Secondary Outcome Measures
Name Time Method Inflammatory cells;Gene sequencing;Inflammatory cytokines;