Intracerebral Hemorrhage
Conditions
Interventions
Experimental group:Guideline-Based Standardized Therapy Plus Jiedu Huayu Traditional Chinese Medicine Formula
Control group :Guideline-Based Standardized Therapy Plus Placebo of the Jiedu Huayu Traditional Chinese Medicine Formula
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Possible or probable cerebral amyloid angiopathy–related intracerebral hemorrhage (CAA-ICH); 2.Onset within 7 days; 3.Primary supratentorial intracerebral hemorrhage with hematoma volume =30 mL; 4.Glasgow Coma Scale (GCS) score =8; 5.National Institutes of Health Stroke Scale (NIHSS) score =25; 6.Age =50 years; 7.Any gender; 8.Subject or legally authorized representative provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known allergy to any component of the investigational traditional Chinese medicine formula; 2.Intracerebral hemorrhage with a clearly identifiable cause, such as vascular malformations, aneurysms, coagulation disorders, use of anticoagulant or antiplatelet therapy, post-thrombolysis, hemorrhagic transformation after infarction, hematologic diseases, Moyamoya disease, or other definite etiologies; 3.Traumatic intracerebral hemorrhage; 4.Active gastrointestinal ulcer or other conditions with a clear risk of rebleeding; 5.Severe hepatic or renal dysfunction (note: severe hepatic dysfunction defined as ALT or AST >3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine >2 times the upper limit of normal); 6.Patients who have received or are scheduled for surgical intervention; 7.Patients with other life-threatening severe diseases and an expected survival of less than 6 months; 8.Presence of other conditions that significantly limit neurological assessment, preclude completion of cranial MRI, or interfere with patient follow-up; 9.Pregnant women, women planning pregnancy, or breastfeeding women; 10.Participation in other interventional clinical trials at present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of vascular events within 180 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of symptomatic vascular events;Changes in neurocognitive function at 180 days;neurological function;changes in quality of life; | — |
Countries
China
Contacts
Public ContactDandan Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed