The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhagic Stroke |
Drug: PG2 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke |
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: PG2 Injection 500 mg
|
|
Placebo Comparator: Placebo
Powder for Injection, 500 ml normal saline, tiw, 2 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Chun-Chung CC Chen, MD | 886-4-22052121 ext 5033 | cck36701@gmail.com |
| Taiwan | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan, 40447 | |
| Principal Investigator: Chun-Chung CC Chen, MD | |
| Sub-Investigator: Der-Yang DY Cho, President | |
| Sub-Investigator: Hung-Lin HL Lin, MD | |
| Sub-Investigator: Chung-Hsiang CH Liu, MD | |
| Sub-Investigator: Chun-Lin CL Liu, MD | |
| Sub-Investigator: Der-Cherng DC Chen, MD | |
| Sub-Investigator: Han-Chung HC Lee, MD | |
| Sub-Investigator: Yen-Tze YT Chu, MD | |
| Sub-Investigator: Hao-Yu HY Chuang, MD | |
| Sub-Investigator: Tsai-Chung TC Li, PhD | |
| Principal Investigator: | Chun-Chung CC Chen, MD | China Medical University Hospital, Taichung, Taiwan |
More Information
No publications provided
| Responsible Party: | PhytoHealth Corporation |
| ClinicalTrials.gov Identifier: | NCT01325233 History of Changes |
| Other Study ID Numbers: | PH-CP018 |
| Study First Received: | March 28, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Taiwan : Food and Drug Administration |
Keywords provided by PhytoHealth Corporation:
|
Astragulus polysaccharides Hemorrhagic stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013