Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): AngongNiuhuang pill; Placebo of AngongNiuhuang pill; Standard treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.; This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.; The other treatments according to guidelines for standard treatment of acute ischemic stroke
Other intervention name(s): Angong Niuhuang Wan; Placebo of Angong Niuhuang Wan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acute Ischemic Stroke; AngongNiuhuang Pill