Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 7 days of placebo
    ARM 1: Kind: Experimental
    Label: B
  • Angongniuhuang Pill Drug
    Intervention Desc: 7 days of Angongniuhuang Pill
    ARM 1: Kind: Experimental
    Label: A

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Glasgow Coma Scale (GCS) within 90 days after stroke onset. 90 days No
Secondary The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma. 90 days No
Secondary Global disability on modified Rankin scale at 90 days. 90 days No
Secondary NIH stroke scale 90 days No
Secondary Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b 14 days Yes

Sponsors