Role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study

Abstract

Background: In Indonesia, the incidence of stroke is growing rapidly every year and it becomes a burden to the government. Medications improving neurological function are required, in order to increase patient′s quality of life. There were an enzyme (lumbrokinase) secreted from the alimentary tract of earthworm and it has anti-thrombotic and thrombolytic effect so that it can be beneficial in the management and prevention of stroke. DLBS1033 is a standardized bioactive protein fraction derived from Lumbricus rubellus through a patented technology of extraction. DLBS1033 has been shown to have antithrombosis and thrombolytic activities. The safety profile of DLBS1033 was also demonstrated in toxicology studies, animal studies, and in healthy adult subjects. Based on its mechanism of action and safety profile, DLBS1033 can be considered beneficial on acute ischemic stroke patients. Through this clinical study, we will evaluate the efficacy and safety of the product in acute ischemic stroke management. Methods/Design: 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 the management of acute ischemic stroke. 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 (as DLBS1033 group). Functional outcomes will be measured using the Modified Rankin Scale (MRS) and The Modified National Institutes of Health Stroke (mNIHSS). Discussion: The study is expected to be a medical breakthrough in acute ischemic stroke management. Therefore, the morbidity and mortality of this disease can be lowered. Trial registration: ClinicalTrials.gov identifier: NCT02362984; registered on 3 February 2015.