The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01325233
First received: March 28, 2011
Last updated: February 27, 2014
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Completion Date: September 2013
Primary Completion Date: September 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325233

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Chun-Chung CC Chen, MD China Medical University Hospital, Taichung, Taiwan
  More Information

Additional 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: February 27, 2014
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 August 20, 2014