Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

1. Male or female participates aged 40-80 years.

2. Diagnosis with acute ischemic stroke.

3. Diagnosis with acute cerebral infarctions of internal carotid artery system.

4. 10≤ Baseline NIHSS <20.

5. Time of onset ≤36h.

6. Provision of informed consent.

Exclusion Criteria:

1. Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.

2. Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.

3. Patients with hemorrhagic transformation after cerebral infarction.

4. Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.

5. Received or planned to receive decompression craniectomy.

6. With mRS score >1 before onset of this episode.

7. Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.

8. With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleeding tendency.

9. With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upper limit or Creatinine >1.5 times than normal upper limit.

10. Allergic to ingredients of AngongNiuhuang pill.

11. Received AngongNiuhuang pill within 1 month.

12. Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.

13. Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.

14. Participates with a life expectancy less than 3 months.

15. Incapable to follow this study due to mental illness, cognitive or emotional disorders.

16. Participates are not eligible for this clinical trial as evaluated by the investigators.