The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

Study Overview
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Brief Summary
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Stroke is one of the most common non-communicable diseases worldwide. It is the leading cause of morbidity and mortality in many countries. Stroke is broadly classified into ischemic and hemorrhagic stroke. Ischemic stroke is more common than hemorrhagic stroke. In Indonesia, the prevalence of ischemic stroke is 42.9% compare to hemorrhagic stroke 19.9%. Ischemic stroke defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. One of the main therapy in ischemic stroke is administration of anti thrombotic agent. DLBS1033 is a bioactive protein fraction isolated from Lumbricus rubellus. DLBS1033 possessed quadruple activities that inhibit platelet aggregation, induces fibrinogenolysis, fibrinolysis, and thrombolysis. This is a new proposed medication nowadays. There is still a limited study about DLBS1033. To our knowledge, research concern on the usage of DLBS1033 in stroke patients is very limited in Indonesia. This study aimed to Measure the benefit of DLBS1033 as add on therapy for ischemic stroke patients. The hypothesis of this study : a. The use of DLBS1033 improve functional status of ischemic stroke patients at hospital discharge. b. The use of DLBS1033 improve functional status 30-days after stroke onset.

Detailed Description
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This was randomized, controlled, open-label, study from the period of April 2020 - August 2020 at Bethesda Hospital, Yogyakarta, Indonesia. There were 180 acute ischemic stroke patients who fulfilled the inclusion and exclusion criteria. Each subject recruited from acute stroke intensive care unit had been followed up from the first day they were hospitalized until hospital discharge (died or discharged alive) and 30 days after the onset. Ethical approval number 1087/C.16/FK/2019 was obtained from Health Research Ethics Committee, Faculty of Medicine Duta Wacana Christian University Yogyakarta. This research has been registered at Center for Health Resources and Services Research and Development Indonesia with the ethical approval number of 1087/C.16/FK/2019.

Official Title
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The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: DLBS1033
* Drug: Aspirin
* Drug: Statin
* Drug: Vit B12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Adult age (>18 years old) Diagnosed with acute ischemic stroke for the first time The onset is <24 hours Not a referral patient GCS score of 15 (fully alert) Mild to moderate scores on NIHSS Exclusion Criteria: Subjects known to have hypersensitivity to DLBS1033 Participated in other studies for the past 1 month Not competent enough in giving approval and answering questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily (control group) or standard therapy and DLBS1033 3 times daily (experimental group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily and DLBS1033 3 times daily (experimental group). | Drug: DLBS1033<br>* DLBS 1033 490 mg tablet 3 times daily<br>* Other names: Disolf;Drug: Aspirin<br>* Aspirin 100 mg tablet once daily<br>Drug: Statin<br>* Atorvastatin 20 mg tablet once daily<br>* Other names: Atorvastatin;Drug: Vit B12<br>* Vit B12 100 mg tablet three times daily<br>|
| Active Comparator: Control Group<br>standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily | Drug: Aspirin<br>* Aspirin 100 mg tablet once daily<br>Drug: Statin<br>* Atorvastatin 20 mg tablet once daily<br>* Other names: Atorvastatin;Drug: Vit B12<br>* Vit B12 100 mg tablet three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in modified Rankin Scale (mRS) scores at hospital discharge | Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value. | At hospital discharge (approximately 4 days after treatment initiation) | 
| Improvement in modified Rankin Scale (mRS) scores at 30 days | Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its hospital discharge value. | 30 days after treatment initiation | 
| Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at hospital discharge | Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its baseline value. | At hospital discharge (approximately 4 days after treatment initiation) | 
| Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 30 days | Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its hospital discharge value. | 30 days after treatment initiation | 
| Improvement in Barthel Index (BI) scores at hospital discharge | Change in functional outcomes as measured by Barthel Index (BI) from its baseline value. | At hospital discharge (approximately 4 days after treatment initiation) | 
| Improvement in Barthel Index (BI) scores at 30 days | Change in functional outcomes as measured by Barthel Index (BI) from its hospital discharge value. | 30 days after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBS1033, Standard therapy, Stroke, Outcomes, Lumbrokinase