The Pilot Clinical Study of PG2 Injection on Hemorrhagic... | NCT01325233

Studies
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

NCT01325233

Sponsor

PhytoHealth Corporation

Status

Completed

Last Update Posted

Jun 4, 2025Actual

Enrollment

61Actual

Phase

Early Phase 1

Conditions

Hemorrhagic Stroke

Interventions

PG2
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PG2 Injection	Experimental	Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks	Drug: PG2
Placebo	Placebo Comparator	Powder for Injection, 500 ml normal saline, tiw, 2 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PG2	Drug	Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks	PG2 Injection

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chun-Chung CC Chen, MD	China Medical University Hospital, Taichung, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital		Taichung		40447	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D000083302	Hemorrhagic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

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Browse Branches

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