- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362984
DLBS1033 for the Treatment of Acute Ischemic Stroke
The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
West Java
-
Sukabumi, West Java, Indonesia, 43113
- RSUD R. Syamsudin, SH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control Group
Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period
|
Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
Other Names:
|
EXPERIMENTAL: DLBS1033 Group
DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period
|
DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in mNIHSS score
Time Frame: 7 days after treatment initiation
|
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value
|
7 days after treatment initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in MRS
Time Frame: 7 days after treatment initiation
|
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value
|
7 days after treatment initiation
|
Improvement in fibrinogen level
Time Frame: 7 days after treatment initiation
|
Change in haemostatic parameter as measured by fibrinogen level from its baseline value
|
7 days after treatment initiation
|
Improvement in d-dimer level
Time Frame: 7 days after treatment initiation
|
Change in haemostatic parameter as measured by d-dimer level from its baseline value
|
7 days after treatment initiation
|
Liver function
Time Frame: 7 days after treatment initiation
|
Liver function measured will be: serum AST, ALT, G-GT, total bilirubin
|
7 days after treatment initiation
|
Renal function
Time Frame: 7 days after treatment initiation
|
Renal function measured will be serum creatinine
|
7 days after treatment initiation
|
Routine hematology
Time Frame: 7 days after treatment initiation
|
Routine hematology measured will be: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
|
7 days after treatment initiation
|
Hemostasis parameters
Time Frame: 7 days after treatment initiation
|
Hemostasis parameters measured will be: PT and aPTT
|
7 days after treatment initiation
|
Adverse events
Time Frame: 7 days after treatment initiation
|
Adverse events, including bleeding events, will be observed and carefully evaluated during the expected average of 7 days of study treatment.
|
7 days after treatment initiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tut W Handayani, Sp.S, MD, RSUD R. Syamsudin, SH
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLBS1033-0614
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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