The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

NCT ID: NCT01325233

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PG2 Injection

Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks

Group Type: EXPERIMENTAL

PG2

Intervention Type: DRUG

Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks

Placebo

Powder for Injection, 500 ml normal saline, tiw, 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

500 ml normal saline, tiw, 2 weeks

Interventions

PG2

Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks

Intervention Type: DRUG

Placebo

500 ml normal saline, tiw, 2 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhytoHealth Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Chung CC Chen, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital, Taichung, Taiwan

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

PH-CP018

Identifier Type: -

Identifier Source: org_study_id