Trial | NCT04425590  Report issue

Title

The Benefit of Add On DLBS1033 for Ischemic Stroke Patient
The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Study

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    180
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.
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.
Study Started
Apr 01
2020
Primary Completion
Aug 31
2020
Anticipated
Study Completion
Aug 31
2020
Anticipated
Last Update
Jun 11
2020

Drug DLBS1033

DLBS 1033 490 mg tablet 3 times daily

  • Other names: Disolf

Drug Aspirin

Aspirin 100 mg tablet once daily

Drug Statin

Atorvastatin 20 mg tablet once daily

  • Other names: Atorvastatin

Drug Vit B12

Vit B12 100 mg tablet three times daily

Experimental Group Experimental

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).

Control Group Active Comparator

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

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
No Results Posted