The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

Duta Wacana Christian University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: DLBS1033; Drug: Aspirin; Drug: Vit B12; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT04425590

INADLBS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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).

Treatment:

Drug: Statin

Drug: Vit B12

Drug: Aspirin

Drug: DLBS1033

Control Group

Active Comparator group

Description:

standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily

Treatment:

Drug: Statin

Drug: Vit B12

Drug: Aspirin