The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

PhytoHealth

Status and phase

Completed

Early Phase 1

Conditions

Hemorrhagic Stroke

Treatments

Drug: Placebo

Drug: PG2

Study type

Interventional

Funder types

Industry

Identifiers

NCT01325233

PH-CP018

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.