Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve 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 effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Affiliated Hospital of Chengde Medical University; Cangzhou Central Hospital; China-Japan Friendship Hospital; The Second Hospital of Hebei Medical University

Criteria

Inclusion Criteria:

1. Acute ischemic stroke.

2. 18 years ≤ age ≤ 80 years.

3. Within 24 hours from symptom onset.

4. Baseline NIHSS range 5 from 20.

5. Provision of informed consent.

Exclusion Criteria:

1. Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.

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

3. Receive thrombolysis or endovascular treatment.

4. mRS>1 at randomization (pre-morbid historical assessment).

5. Thrombocytopenia(<100×10*9/L) , hematologic diseases and other systemic bleeding tendency.

6. Sleepy head (GCS≤7).

7. Alanine transaminase > 1.5 times normal upper limit or Aspartate aminotransferase > 1.5 times normal upper limit.

8. Glomerular filtration rate<60 ml/min/1.73m2.

9. Patients who have been taking AngongNiuhuang pills within 3 months.

10. Pregnancy or lactation, women in childbearing age with negative pregnancy test refuse to accept contraception.

11. Participate in clinical studies of other research drugs within the last 30 days.

12. Patients with a life expectancy of less than three months.

13. Incapable to follow this study for mental illness, cognitive or emotional disorders.

14. Unsuitable for this study in the opinion of the investigators.