The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

NCT01325233 | Completed Early Phase 1

• 1 other identifier: PH-CP018
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke

Keywords

Astragulus polysaccharides; Hemorrhagic stroke

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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.

  These index will be detected on day 1 (baseline, before study drug treatment), day 4 and day 7.

Study Arms (2)

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

PG2 DRUG

Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks

PG2 Injection

Placebo DRUG

500 ml normal saline, tiw, 2 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chun-Chung CC Chen, MD

  China Medical University Hospital, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (1)