Optimal intervention time and risk of the Activating Blood and Removing Stasis Method in acute cerebral hemorrhage patients: A Randomized Placebo-Controlled Trial
- Conditions
- Acute Cerebral Hemorrhage
- Registration Number
- ITMCTR1900002289
- Lead Sponsor
- The Affiliated Hospital to Changchun University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patient diagnosed to be cerebral hemorrhagic stroke and confirmed by CT;
2. Age 35 to 80 years;
3. The stroke onset time is within 24-72h;
4. Patients receive conservative treatment of conventional medicine;
5. Glasgow Coma Score > 6 points;
6. The modified Rankin Scale Score before the onset is 0 to 1 point;
7. Inform-consented;
1. Confirmed cerebral hemorrhage that is caused by brain tumor, blood disease, brain trauma (or postoperative);
2. Patients with coma or patients with cerebral hernia at the onset of the cerebral hemorrhage;
3. Those who cannot take the study drug by orall or nasal feeding because of gastrointestinal bleeding;
4. Patients need emergency surgery;
5. Patients with subarachnoid hemorrhage;
6. Women who are pregnant or lactating;
7. Patients with severe primary diseases such as cardiovascular, hepatic, renal and hematopoietic systems diseases, and mental diseases. Patients with abnormal (doubled level) conventional coagulation examinations, liver function and kidney function.
8. Allergic constitution or known allergy to alcohol or ingredients of Chinese medicine BSR.
9. Hemorrhagic stroke induced by taking anticoagulant drugs;
10. Patients who participated in other clinical trials in the recent 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of disability (modified Ranking Scale, mRS);
- Secondary Outcome Measures
Name Time Method The degree of disability (modified Ranking Scale, mRS);National Institute of Health stroke scale (NIHSS);Mortality rate due to cerebral hemorrhage;Percentage of hematoma enlargement after taking the drug in patients within 72 hours of onset;Ability of daily life (Barthel?Index);All-cause mortality;Traditional Chinese Medicine Stroke Syndrome Evaluation Scale;