The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

June 7, 2020 updated by: Rizaldy Taslim Pinzon, Duta Wacana Christian University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Special Region Of Yogyakarta
      • Yogyakarta, Special Region Of Yogyakarta, Indonesia, 55224
        • Recruiting
        • Bethesda Hospital Yogyakarta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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).
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
Active Comparator: Control Group
standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in modified Rankin Scale (mRS) scores at hospital discharge
Time Frame: At hospital discharge (approximately 4 days after treatment initiation)
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value.
At hospital discharge (approximately 4 days after treatment initiation)
Improvement in modified Rankin Scale (mRS) scores at 30 days
Time Frame: 30 days after treatment initiation
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its hospital discharge value.
30 days after treatment initiation
Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at hospital discharge
Time Frame: At hospital discharge (approximately 4 days after treatment initiation)
Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its baseline value.
At hospital discharge (approximately 4 days after treatment initiation)
Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 30 days
Time Frame: 30 days after treatment initiation
Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its hospital discharge value.
30 days after treatment initiation
Improvement in Barthel Index (BI) scores at hospital discharge
Time Frame: At hospital discharge (approximately 4 days after treatment initiation)
Change in functional outcomes as measured by Barthel Index (BI) from its baseline value.
At hospital discharge (approximately 4 days after treatment initiation)
Improvement in Barthel Index (BI) scores at 30 days
Time Frame: 30 days after treatment initiation
Change in functional outcomes as measured by Barthel Index (BI) from its hospital discharge value.
30 days after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duta Wacana Christian University

Collaborators

Dexa Laboratories Of Biomolecular Science

Investigators

  • Principal Investigator: Rizaldy Pinzon, MD, MSc, PhD, Duta Wacana Christian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INADLBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on DLBS1033

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe