Back to resultsThe Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
Primary Purpose
Hemorrhagic Stroke
Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
PG2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Stroke focused on measuring Astragulus polysaccharides, Hemorrhagic stroke
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.
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PG2 Injection
Placebo
Arm Description
Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
Powder for Injection, 500 ml normal saline, tiw, 2 weeks
Outcomes
Primary Outcome Measures
Functional Independence Measure (FIM)
Secondary Outcome Measures
Other clinical symptoms including Glasgow outcome scale (GOS), modified rankin scale (MRS), and Barthel Index (BI)
Inflammatory index including C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein, IL-1, IL-6, and TNF-beta levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01325233
Brief Title
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
Official Title
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke
Keywords
Astragulus polysaccharides, Hemorrhagic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PG2 Injection
Arm Type
Experimental
Arm Description
Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Powder for Injection, 500 ml normal saline, tiw, 2 weeks
Intervention Type
Drug
Intervention Name(s)
PG2
Intervention Description
Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 ml normal saline, tiw, 2 weeks
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Time Frame
FIM will be evaluated on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84.
Secondary Outcome Measure Information:
Title
Other clinical symptoms including Glasgow outcome scale (GOS), modified rankin scale (MRS), and Barthel Index (BI)
Time Frame
These clinical symptoms will be evaluated on on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84.
Title
Inflammatory index including C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein, IL-1, IL-6, and TNF-beta levels.
Time Frame
These index will be detected on day 1 (baseline, before study drug treatment), day 4 and day 7.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Chung CC Chen, MD
Organizational Affiliation
China Medical University Hospital, Taichung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
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