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Optimal intervention time and risk of the Activating Blood and Removing Stasis Method in acute cerebral hemorrhage patients: a Randomized Placebo-Controlled Trial

Optimal intervention time and risk of the Activating Blood and Removing Stasis Method in acute cerebral hemorrhage patients: a Randomized Placebo-Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022627
Enrollment
Unknown
Registered
2019-04-19
Start date
2019-05-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cerebral Hemorrhage

Interventions

Sponsors

The Affiliated Hospital to Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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;

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The degree of disability (modified Ranking Scale, mRS);

Secondary

MeasureTime frame
Percentage of hematoma enlargement after taking the drug in patients within 72 hours of onset;Ability of daily life (Barthel Index);Mortality rate due to cerebral hemorrhage;All-cause mortality;National Institute of Health stroke scale (NIHSS);Traditional Chinese Medicine Stroke Syndrome Evaluation Scale;The degree of disability (modified Ranking Scale, mRS);

Countries

China

Contacts

Public ContactWang Jian

The Affiliated Hospital to Changchun University of Chinese Medicine

jian-w222@163.com+86 15948000772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026