Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ShuGuang Hospital

Criteria

Inclusion Criteria:

1. Meet the diagnostic criteria of acute intracerebral hemorrhage；

2. CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;

3. The time from onset to confirmed diagnosis by CT scan is within 4 hours;

4. Enrolled and receive treatment within 12 hours from onset;

5. Age ≥18 years old;

6. Obtain approval from the patient or family members.

Exclusion Criteria:

1. The time from onset to confirmed diagnosis by CT scan is over 4 hours;

2. CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);

3. The volume of hematoma is above 80ml;

4. Glasgow Coma Scale (GCS) is ≤ 5 points;

5. The time from onset to confirmed diagnosis is over 12 hours;

6. Have a surgical treatment planning within 24 hours;

7. Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;

8. Patients with disabilities before onset (modified mRS score > 2);

9. Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;

10. Patients who have participated in other clinical trials within the past 1 month;

11. Pregnant or nursing women;

12. Allergic constitution (allergic to more than two kinds of food or medications).