NCT01325233

The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: PhytoHealth Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Hemorrhagic Stroke

Interventions

Type	Name	Description
DRUG	PG2	Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
DRUG	Placebo	500 ml normal saline, tiw, 2 weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-03-29
• Last updated: 2025-06-04

Locations

1 site across 1 country: Taiwan