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Completed

NCT Number: NCT01325233

The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

China Medical University Hospital

Taichung, 40447, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PG2

Drug

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

Placebo

Drug

500 ml normal saline, tiw, 2 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

PhytoHealth Corporation

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2011
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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