drugset / Trial / NCT04425590

The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

NCT04425590

RandomizedParallel-groupOpen-labelSupportive care

Summary

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.

Timeline

Start
2020-04-01
Primary completion
2020-08
Completion
2020-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS 1033 490 mg tablet 3 times daily Protein / enzyme biologic 490 mg
Background Aspirin Small molecule 100 mg
Background Atorvastatin Small molecule 20 mg
Background Vitamin B12 Other / unclassified 100 mg

Indications