Intracerebral hemorrhage (ICH)
Conditions
Interventions
Treatment Group:Xingnaojing injection+Naoxueshu oral liquid
Control Group:Xingnaojing injection placebo+Naoxueshu oral liquid placebo
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of primary ICH. 2. Xingnaojing injection can be initiated within 72 hours of symptoms onset. 3. Total scores on NIHSS of 4 or greater at randomization. 4. Total scores on GCS of 9 or greater at randomization. 5. Aged 18 to 80 years. 6. Informed consent obtained by subject or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Known allergy to Xingnaojing injection, Naoxueshu oral liquid or related pharmaceutical ingredients. 2. Prior history of stroke with scores on mRS of 2 or greater before onset. 3. ICH is due to CAA, vascular malformation, aneurysms, Moyamoya disease, primary or metastatic neoplasms, cerebral venous sinus thrombosis, vasculitis, hemorrhagic transformation of cerebral infarction, hematological or coagulation diseases, or secondary to thrombolysis or antithrombotic treatment. Primary intraventricular hemorrhage. 4. ICH is considered to be related to trauma. 5. Gastrointestinal bleed or bleed tendency, including active gastrointestinal ulcer. 6. Severe hepatic or renal insufficiency (ALT or AST exceeds 3-fold of upper limits of normal or creatinine exceeds 2-fold of upper limits of normal). 7. Patient is considered a candidate for surgical interventions, including hematoma evacuation, external ventricular drainage and ventriculo-peritoneal shunt, etc. 8. Other severe comorbidity with life expectancy < 3 months. 9. Difficulty to participate in neurologic assessment or clinical follow-up due to known comorbidity. 10. Current or expected pregnancy or active lactation. 11. Subject is currently participating in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin score (mRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institute of Health stroke scale (NIHSS);Hematoma volume;Peri-hematoma edema volume;Barthel Index (BI);Glasgow Coma Scale (GCS);Stroke Patient Report Outcome (Stroke-PRO);EQ-5D;Montreal Cognitive Assessment (MoCA); | — |
Countries
China
Contacts
Public ContactXingquan Zhao
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed