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.

Study Overview

• Status: Completed
• Conditions: Hemorrhagic Stroke
• Intervention / Treatment: Drug: PG2; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG2 Injection; Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks	Drug: PG2; Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
Placebo Comparator: Placebo; Powder for Injection, 500 ml normal saline, tiw, 2 weeks	Drug: Placebo; 500 ml normal saline, tiw, 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Independence Measure (FIM)	FIM will be evaluated on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation
• Investigators: Principal Investigator: Chun-Chung CC Chen, MD, China Medical University Hospital, Taichung, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimated): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hemorrhagic stroke; Astragulus polysaccharides
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: PH-CP018