The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

• Status: Recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duta Wacana Christian University
• Collaborator: Dexa Laboratories Of Biomolecular Science
• Treatments: Aspirin; Atorvastatin

Criteria

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