NCT01790997

Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

Detailed description

There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens : * Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal * Treatment II : 1 tablet of aspirin 80 mg once daily, after meal * Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication. Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	DLBS1033	1 tablet of DLBS1033 490 mg thrice daily, after meal
DRUG	Aspirin	1 tablet of aspirin 80 mg once daily, after meal
DRUG	Clopidogrel	1 tablet of clopidogrel 75 mg once daily, after meal

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-02-13
• Last updated: 2014-06-04

Locations

1 site across 1 country: Indonesia