The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Hemorrhagic Stroke Clinical Trial

Official title:

The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325233
• Other study ID #: PH-CP018
• Status: Completed
• Phase: Early Phase 1
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Stroke

Intervention

Drug:
• PG2
Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
• Placebo
500 ml normal saline, tiw, 2 weeks

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Measure (FIM)		FIM will be evaluated on day 1 (baseline, before study drug treatment), day 7, day 28 and day 84.
Secondary	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.
Secondary	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.