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Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.
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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. It is hypothesized that the improvement in functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS group will be significantly greater than those in the control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 3 x 1 tablet, given everyday for 28 days of study period |
|
| DLBS1033 | Experimental | DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS1033 | Drug | Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | Change in functional outcomes as measured by NIHSS from its baseline value | 3, 7, 14, and 28 days after study medication |
| Barthel Index (BI) | Change in functional outcomes as measured by BI from its baseline value | 3, 7, 14, and 28 days after study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombocyte Aggregation Test (TAT) | Change in haemostatic parameter as measured by TAT from its baseline value | 3, 7, 14, and 28 days after study medication |
| Fibrinogen level | Change in haemostatic parameter as measured by fibrinogen level from its baseline value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulus Sugianto, Sp.S(K), Dr, MD | Indonesia's Neurologists Organization (Perdossi) | Study Chair |
| 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 | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Department, Dr. Kariadi General Hospital | Semarang | Central Java | Indonesia | |||
| Universitas Sebelas Maret (UNS) Hospital |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C559131 | DLBS 1033 |
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|
| Placebo | Drug | Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet |
|
| 3, 7, 14, and 28 days after study medication |
| D-dimer level | Change in haemostatic parameter as measured by d-dimer level from its baseline value | 3, 7, 14, and 28 days after study medication |
| Liver function | Liver function measured includes: serum AST, ALT, gamma-GT, total bilirubin | 7 and 28 days after study medication |
| Renal function | Renal function measured includes: serum creatinine | 7 and 28 days after study medication |
| Routine hematology | Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count | 7 and 28 days after study medication |
| Adverse events | Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study | 1 - 28 days |
| Principal Investigator |
| Rivan Danuaji, Sp.N(K), MD | Neurology Department Dr. Moewardi Hospital | Principal Investigator |
| Hanindia R. Prabaningtyas, Sp.S(K), MD | Neurology Department Universitas Sebelas Maret (UNS) Hospital | Principal Investigator |
| Sukoharjo |
| Central Java |
| Indonesia |
| Dr. Moewardi Hospital | Surakarta | Central Java | Indonesia |
| Neurology Department Fatmawati Regional General Hospital | Jakarta | DKI Jakarta | Indonesia |
| Neurology Department, Budhi Asih Hospital | Jakarta | DKI Jakarta | Indonesia |
| Neurology Department, Pasar Rebo Hospital | Jakarta | DKI Jakarta | Indonesia |
| Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih | Jakarta Pusat | DKI Jakarta | Indonesia |
| Neurology Department Sidoarjo Regional General Hospital | Sidoarjo | East Java | Indonesia |
| Neurology Department, Haji Surabaya Hospital | Surabaya | East Java | Indonesia |
| Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital | Surabaya | East Java | Indonesia |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |