DLBS1033 for the Treatment of Acute Ischemic Stroke

Terminated

Phase 3 Results N/A

Update History

5 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in Sukabumi.
New
The overall status was removed for RSUD R. Syamsudin, SH.
5 Aug '16
The eligibility criteria were updated.
New
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).
Old
Inclusion Criteria: - Male or female subjects with age of 18-65 years . - Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan. - Modified Rankin Scale (MRS) score > 2. - Modified National Institutes of Health Stroke Scale (mNIHSS) score of 5-15. - 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 (when 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.
12 Aug '15
Trial name was updated.
New
DLBS1033 for the Treatment of Acute Ischemic Stroke
The description was updated.
New
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily. After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.
Old
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily. After hospital admission and diagnosis, patient will be handled as per acute ischemic stroke management. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.
The eligibility criteria were updated.
New
Inclusion Criteria: - Male or female subjects with age of 18-65 years . - Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan. - Modified Rankin Scale (MRS) score > 2. - Modified National Institutes of Health Stroke Scale (mNIHSS) score of 5-15. - 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 (when 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.
Old
Inclusion Criteria: - Male or female subjects with age of 18-65 years . - Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan. - Modified Rankin Scale (MRS) score > 2. - Modified National Institutes of Health Stroke Scale (mNIHSS) score of 5-15. - 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. - Recent serious cardiovascular conditions - Presence of severe renal or hepatic dysfunction - Presence of acute or chronic infections. - Thrombocytopenia (when thrombocytes level < 150.000/ul). - Patients with higher risks of bleeding. - Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.