The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Completed

Phase 0 Results N/A

Trial Description

Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of studies have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. PG2, a sterile powder of polysaccharides isolated from the root of astragulus (Huang-Chi) for intravenous injection, has been approved as a botanical drug by TFDA. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the efficacy of PG2 on hemorrhagic stroke.

Detailed Description

This will be a double-blind, randomized, placebo-controlled study. An estimated 60 (at least 48 evaluable) first hemorrhagic stroke patients will be randomly divided into the control and treatment groups. Each group will be treated as follows: 1) control group will accept placebo t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.; 2) treatment group will accept PG2 t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment. Inflammatory index including the levels of C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein, IL-1, IL-6, and TNF-beta levels will be measured and clinical symptoms including Glasgow outcome scale (GOS), modified rankin scale (MRS), Functional Independence Measure (FIM) and Barthel Index (BI) will be evaluated during this study.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 500 ml normal saline, tiw, 2 weeks
    ARM 1: Kind: Experimental
    Label: Placebo
  • PG2 Drug
    Intervention Desc: Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
    ARM 1: Kind: Experimental
    Label: PG2
    ARM 2: Kind: Experimental
    Label: PG2 Injection
    Description: Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Independence Measure (FIM) FIM will be evaluated on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84. No
Secondary Other clinical symptoms including Glasgow outcome scale (GOS), modified rankin scale (MRS), and Barthel Index (BI) These clinical symptoms will be evaluated on on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84. No
Secondary Inflammatory index including C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein, IL-1, IL-6, and TNF-beta levels. These index will be detected on day 1 (baseline, before study drug treatment), day 4 and day 7. No

Sponsors