Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma

Exclusion Criteria

• •1. Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.
• •2. Progressive or apparent neurological deficit with a GCS score \< 14 or mRS score \> 2.
• •3. Midline shift \> 10 mm on the radiological image.
• •4. Previous medication treatment for CSDH.
• •5. Previous intracranial surgery for any other neurological disorder.
• •6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.
• •7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.
• •8. Malignant tumors.
• •9. Life expectancy of \< 1 year.
• •10. Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase \> 120 U/L).
• •11. Severe renal impairment (estimated glomerular filtration rate \< 30 ml/min or serum creatinine \> 150 μmol/L).
• •12. Moderate or severe anemia (hemoglobin ≤ 90 g/L).
• •13. Severe coagulopathy or a high risk of life-threatening bleeding.
• •14. Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.
• •15. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.
• •16. Difficulty swallowing oral medication.
• •17. Pregnancy or lactation.
• •18. Participating in another study.