Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
NCT ID: NCT01790997
Last Updated: 2014-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
126 participants
INTERVENTIONAL
2012-05-31
2013-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment I
1 tablet of DLBS1033 490 mg thrice daily, after meal
DLBS1033
1 tablet of DLBS1033 490 mg thrice daily, after meal
Treatment II
1 tablet of aspirin 80 mg once daily, after meal
Aspirin
1 tablet of aspirin 80 mg once daily, after meal
Treatment III
1 tablet of clopidogrel 75 mg once daily, after meal
Clopidogrel
1 tablet of clopidogrel 75 mg once daily, after meal
Interventions
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DLBS1033
1 tablet of DLBS1033 490 mg thrice daily, after meal
Aspirin
1 tablet of aspirin 80 mg once daily, after meal
Clopidogrel
1 tablet of clopidogrel 75 mg once daily, after meal
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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Dexa Medica Group
INDUSTRY
Responsible Party
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Principal Investigators
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Ismail Setyopranoto, dr., SpS(K)
Role: PRINCIPAL_INVESTIGATOR
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
Locations
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Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
Yogyakarta, Jogjakarta, Indonesia
Countries
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Other Identifiers
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DLBS1033-UST-001.11
Identifier Type: -
Identifier Source: org_study_id
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