Completed

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

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What is being tested

DLBS1033

+ Aspirin

+ Clopidogrel

Drug
Who is being recruted

Brain Diseases+5

+ Cardiovascular Diseases

+ Central Nervous System Diseases

From 20 to 80 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorDexa Medica Group
Last updated: June 4, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01790997
Principal SponsorDexa Medica Group
Last updated: June 4, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStrokeIschemic Stroke

Criteria

4 inclusion criteria required to participate
Having non-bleeding stroke in CT scan examination
Having stroke attack onset <= 96 hours
Living in 100 km from RSUP Dr Sardjito Jogjakarta
Male and female subjects aged 20-80 years old
7 exclusion criteria prevent from participating
Have been regularly taking anti-aggregation agent
Having Transient Ischemic Attack (TIA)
Having intracerebral and subarachnoid bleeding stroke
Having recurrence stroke
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
1 tablet of DLBS1033 490 mg thrice daily, after meal

Group II

Active Comparator
1 tablet of aspirin 80 mg once daily, after meal

Group III

Active Comparator
1 tablet of clopidogrel 75 mg once daily, after meal

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital

Yogyakarta, IndonesiaOpen Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital in Google Maps
CompletedOne Study Center