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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.
There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment I | Experimental | 1 tablet of DLBS1033 490 mg thrice daily, after meal |
|
| Treatment II | Active Comparator | 1 tablet of aspirin 80 mg once daily, after meal |
|
| Treatment III | Active Comparator | 1 tablet of clopidogrel 75 mg once daily, after meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS1033 | Drug | 1 tablet of DLBS1033 490 mg thrice daily, after meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in INR value | Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PT | Change in PT (prothrombin time) from baseline to end of study (Month 3rd) | 3 Months |
| Change in aPTT | Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismail Setyopranoto, dr., SpS(K) | Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital | Yogyakarta | Special Region of Yogyakarta | 55281 | Indonesia |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C559131 | DLBS 1033 |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin |
| Drug |
1 tablet of aspirin 80 mg once daily, after meal |
|
| Clopidogrel | Drug | 1 tablet of clopidogrel 75 mg once daily, after meal |
|
| 3 Months |
| Change in Gadjah Mada Stroke Scale | Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd) | 3 Months |
| Change in Barthel Index | Change in Barthel Index from baseline to end of study (Month 3rd) | 3 Months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |