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The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

NCT04425590 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DLBS1033

DLBS 1033 490 mg tablet 3 times daily

DRUG

Aspirin

Aspirin 100 mg tablet once daily

DRUG

Statin

Atorvastatin 20 mg tablet once daily

DRUG

Vit B12

Vit B12 100 mg tablet three times daily

Sponsors & Collaborators

  • Dexa Laboratories Of Biomolecular Science

    collaborator UNKNOWN

  • Duta Wacana Christian University

    lead OTHER

Principal Investigators

  • Rizaldy Pinzon, MD, MSc, PhD · Duta Wacana Christian University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Indonesia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425590 on ClinicalTrials.gov