The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PhytoHealth Corporation

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.