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

Acute Ischemic Stroke Clinical Trial

Official title: Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke

Status Completed

Clinical Trial 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.

Clinical Trial Description

This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial. Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1pill qd/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1pill qd/day for 5-day. 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. The study was consisted of six visits, including the day of randomization, 2 days, 3-6 days, 7 days (the endap time of the therapy), 14 days, and 90 days (the endap time of the follow-up). Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The period of the trial is from August 2020 to October 2021, and 120 subjects are planned to be recruited from 10 centers in China. All the related investigative organizations and individuals will obey the Declaration of Helsinki and Chinese Guard-cell protoplast (GCP) standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. ;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT04475328
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2020
• Completion date: July 30, 2022