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

Last updated: September 8, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Completed

Phase

3

Condition

Stroke

Blood Clots

Cardiac Ischemia

Treatment

Placebo of AngongNiuhuang pill

AngongNiuhuang pill

Standard treatment

Clinical Study ID

NCT04475328
PUMCH-AGNH2020
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Not suitable for taking this medicine according to the judgement of consultingtraditional Chinese medical doctor.
  2. Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and otherbrain organic diseases.
  3. Patients with hemorrhagic transformation after cerebral infarction.
  4. Received or planned to receive endovascular treatment, including thrombectomy, ultraearly 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 automaticdefibrillator or having claustrophobia.
  8. With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleedingtendency.
  9. With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upperlimit 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 agewith negative pregnancy test but refuse to accept contraception; during pregnancy orlactation.
  13. Participates in other clinical trials within 30 days before randomization or currentlyinvolved 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 emotionaldisorders.
  16. Participates are not eligible for this clinical trial as evaluated by theinvestigators.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Placebo of AngongNiuhuang pill
Phase: 3
Study Start date:
October 01, 2020
Estimated Completion Date:
July 30, 2022

Study 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.

Connect with a study center

  • Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing

    Beijing, Beijing 100730
    China

    Site Not Available

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