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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02362984 |
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Date of registration:
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03/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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DLBS1033 for the Treatment of Acute Ischemic Stroke
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Scientific title:
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The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02362984 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Tut W Handayani, Sp.S, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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RSUD R. Syamsudin, SH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects with age of 18-75 years .
- Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
- Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
- Patients present at hospital and receiving first dose of study medication within 72
hours after the onset of the stroke symptoms.
- Able to take oral medication.
Exclusion Criteria:
- For females of childbearing potential: pregnancy and lactation period.
- History of or current hemorrhagic stroke (within the last 3 months).
- Transient ischemic stroke (TIA).
- Patients with seizure at the onset of stroke.
- History of serious head injury within the last 3 months.
- History of major surgery within the last 3 months.
- Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV
(NYHA classification), aorta dissection, and atrial fibrillation within the last 6
months.
- Presence of severe renal or hepatic dysfunction
- Presence of acute or chronic infections.
- Thrombocytopenia (thrombocytes level < 150.000/ul).
- Patients with higher risks of bleeding.
- Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood
pressure > 110 mmHg).
- Random plasma glucose >= 200 mg/dL.
- Current or regular use of oral anticoagulants, antiplatelets other than study
medication, and herbal medicines.
- Hypersensitive to the investigational product(s).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Ischemic Stroke
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Intervention(s)
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Drug: DLBS1033
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Drug: Placebo
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Primary Outcome(s)
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Improvement in mNIHSS score
[Time Frame: 7 days after treatment initiation]
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Secondary Outcome(s)
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Improvement in d-dimer level
[Time Frame: 7 days after treatment initiation]
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Improvement in MRS
[Time Frame: 7 days after treatment initiation]
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Hemostasis parameters
[Time Frame: 7 days after treatment initiation]
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Improvement in fibrinogen level
[Time Frame: 7 days after treatment initiation]
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Renal function
[Time Frame: 7 days after treatment initiation]
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Routine hematology
[Time Frame: 7 days after treatment initiation]
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Adverse events
[Time Frame: 7 days after treatment initiation]
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Liver function
[Time Frame: 7 days after treatment initiation]
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Secondary ID(s)
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DLBS1033-0614
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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