DLBS1033 for the Treatment of Acute Ischemic Stroke

Status Terminated

Clinical Trial Summary

This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.

Clinical Trial Description

Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.

After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02362984
Study type	Interventional
Source	Dexa Medica Group
Contact
Status	Terminated
Phase	Phase 3
Start date	October 2014
Completion date	April 2017

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