The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Conditions
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Hemorrhagic Stroke

Intervention / Treatment
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* Drug: PG2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG2 Injection<br>Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks | Drug: PG2<br>* Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks<br>|
| Placebo Comparator: Placebo<br>Powder for Injection, 500 ml normal saline, tiw, 2 weeks | Drug: Placebo<br>* 500 ml normal saline, tiw, 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astragulus polysaccharides, Hemorrhagic stroke