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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790997

Enrollment

126

Registered

2013-02-13

Start date

2012-05-31

Completion date

2013-12-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

DLBS1033, Lumbrokinase, Acute ischemic stroke, Bleeding profile, Clinical outcome, Aspirin, Clopidogrel

Brief 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.

Interventions

DRUGDLBS1033

1 tablet of DLBS1033 490 mg thrice daily, after meal

DRUGAspirin

1 tablet of aspirin 80 mg once daily, after meal

DRUGClopidogrel

1 tablet of clopidogrel 75 mg once daily, after meal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Male and female subjects aged 20-80 years old * Having non-bleeding stroke in CT scan examination * Having stroke attack onset ≤ 96 hours * Living in 100 km from RSUP Dr Sardjito Jogjakarta

Exclusion criteria

* Having recurrence stroke * Having Transient Ischemic Attack (TIA) * Have been regularly taking anti-aggregation agent * Having intracerebral and subarachnoid bleeding stroke * Subjects and their family do not know when the stroke symptoms appeared * History of haemostasis disorder * History of or will have surgery within 6 months prior to screening

Design outcomes

Primary

Measure	Time frame	Description
Change in INR value	3 Months	Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)

Secondary

Measure	Time frame	Description
Change in PT	3 Months	Change in PT (prothrombin time) from baseline to end of study (Month 3rd)
Change in aPTT	3 Months	Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)
Change in Gadjah Mada Stroke Scale	3 Months	Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)
Change in Barthel Index	3 Months	Change in Barthel Index from baseline to end of study (Month 3rd)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026