DLBS1033 for Acute Ischemic Stroke Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Ischemic Stroke
- Lacunar Anterior Circulation Infarct
- Partial Anterior Circulation Infarct
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects in this study will be screened consecutively and eligible subjects will be randomized into two groups and receive the investigational drug, DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to standard therapy for 28-days course of therapy. Standard therapy used in t...
Subjects in this study will be screened consecutively and eligible subjects will be randomized into two groups and receive the investigational drug, DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to standard therapy for 28-days course of therapy. Standard therapy used in this study will consist of: aspirin 80 mg, simvastatin 20 mg, and vitamin B complex. After hospital admission and diagnosis, patient will be handled as per acute ischemic stroke management in each study site. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study treatments. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline and 3, 7,14, and 28 days after study medication initiation; while safety examinations will be performed at the same time point, but 3 and 14 days after study medication initiation.
Tracking Information
- NCT #
- NCT02133521
- Collaborators
- Not Provided
- Investigators
- Study Director: Hasan Machfoed, Prof, Sp.S(K), MD Neurology Department Dr. Soetomo Hospital Study Chair: Paulus Sugianto, Sp.S(K), Dr, MD Indonesia's Neurologists Organization (Perdossi) Principal Investigator: Muh. Hamdan, Sp.S(K), MD Neurology Department Dr. Soetomo Hospital Principal Investigator: Dodik Tugasworo, Sp.S(K), MD Neurology Department Dr. Kariadi General Hospital Principal Investigator: Dian Cahyani, Sp.S, MD Neurology Department Budhi Asih Hospital Principal Investigator: Diah H Soeryaningtias, Sp.S, MD Neurology Department Haji Surabaya Hospital Principal Investigator: Gotot S PW, Sp.S, MD Neurology Department Pasar Rebo Hospital Principal Investigator: Sugeng Wijayanto, Sp.S, MD Neurology Department Sidoarjo Regional General Hospital Principal Investigator: Ika Y Margaretha, Sp.S, MD Neurology Department Fatmawati Regional General Hospital Principal Investigator: Wiwin Sundawiyani, Sp.S, MD Islam Jakarta Hospital (RSIJ) Cempaka Putih
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