The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
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.
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.
Inclusion Criteria:

 -  Patients who confirmed diagnosis of first spontaneous hemorrhagic stroke

 -  Patients with hemorrhagic stroke in Putamen

 -  Patients who admitted to the hospital within 24 hours of onset of hemorrhagic stroke

 -  Patients who signed the informed consent form

 Exclusion Criteria:

 -  Patient with hemorrhage in the area out of Putamen or primary subarachnoid hemorrhage,
 Arteriovenous malformation (AVM) or brain tumor hemorrhage

 -  Patient who performed craniotomy

 -  Patient who suffering from cirrhosis, uremia with dialysis, bleeding tendency, severe
 cardiopulmonary disease or mental disorders would be unable to comply with the study
 by investigators' decision.

 -  Patients have enrolled or have not yet completed other investigational drug trials
 within 1 month before screening.

 -  Female patients are pregnant or breast-feeding.