This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.
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.
Trial Stopped: Major technical hindrance in recruitment.
- Placebo Drug
Intervention Desc: 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 ARM 1: Kind: Experimental Label: Control Group Description: Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period
- DLBS1033 Drug
Other Names: Disolf Intervention Desc: 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 ARM 1: Kind: Experimental Label: DLBS1033 Group Description: DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Improvement rate in MRS||7 days after treatment||No|
|Secondary||Improvement in mNIHSS||3 and 7 days after treatment||No|
|Secondary||Improvement in fibrinogen level||7 days after treatment||No|
|Secondary||Improvement in d-dimer level||7 days after treatment||No|
|Secondary||Liver function||7 days after treatment||Yes|
|Secondary||Renal function||7 days after treatment||Yes|
|Secondary||Routine hematology||7 days after treatment||Yes|
|Secondary||Hemostasis parameters||7 days after treatment||Yes|
|Secondary||Adverse events||Along the course of the study||Yes|
|Primary||Improvement in mNIHSS score||7 days after treatment initiation||No|
|Secondary||Improvement in MRS||7 days after treatment initiation||No|
- Dexa Medica Group Lead