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Ischemic StrokePhase 2/3NCT04425590

The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

A Phase 2/3 study testing DLBS1033, Aspirin and Statin in people with Ischemic Stroke, run by Duta Wacana Christian University at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
DLBS1033, Aspirin and Statin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteIndonesia
Study dates
1 Apr 2020to Aug 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Rizaldy T Pinzon, MD, MSc, PhD contact

+62 81294638229

drpinzon17@gmail.com

Vanessa Veronica contact

+62 89605559529

vanessaveronica73@gmail.com

Indonesia1 site, 1 recruiting

  • Bethesda Hospital Yogyakarta

    Yogyakarta, Special Region of Yogyakarta, 55224

    Rizaldy T Pinzon, MD, MSc, PhD, +62 81294638229, drpinzon17@gmail.com

    Recruiting

Other trials in Indonesia

About this study

Official title: 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.

Read more

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 :

  1. 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.
Read the 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.

Conditions
Ischemic Stroke
Being tested
DLBS1033, Aspirin, Statin, Vit B12
Keywords
DLBS1033, Standard therapy, Stroke, Outcomes, Lumbrokinase
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLBS1033Drug

    Also called Disolf

    DLBS 1033 490 mg tablet 3 times daily

  • AspirinDrug

    Aspirin 100 mg tablet once daily

  • StatinDrug

    Also called Atorvastatin

    Atorvastatin 20 mg tablet once daily

  • Vit B12Drug

    Vit B12 100 mg tablet three times daily

Study groups in NCT04425590
Study groupRoleWhat they receive
Experimental GroupExperimentalstandard 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).
Receives: Drug: DLBS1033; Drug: Aspirin; Drug: Statin; Drug: Vit B12
Control GroupActive comparatorstandard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily
Receives: Drug: Aspirin; Drug: Statin; Drug: Vit B12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in modified Rankin Scale (mRS) scores at hospital discharge

    Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value.

    Measured: At hospital discharge (approximately 4 days after treatment initiation)

  2. Improvement in modified Rankin Scale (mRS) scores at 30 days

    Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its hospital discharge value.

    Measured: 30 days after treatment initiation

  3. Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at hospital discharge

    Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its baseline value.

    Measured: At hospital discharge (approximately 4 days after treatment initiation)

  4. Improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 30 days

    Change in functional outcomes as measured by National Institutes of Health Stroke Scale (NIHSS) from its hospital discharge value.

    Measured: 30 days after treatment initiation

  5. Improvement in Barthel Index (BI) scores at hospital discharge

    Change in functional outcomes as measured by Barthel Index (BI) from its baseline value.

    Measured: At hospital discharge (approximately 4 days after treatment initiation)

  6. Improvement in Barthel Index (BI) scores at 30 days

    Change in functional outcomes as measured by Barthel Index (BI) from its hospital discharge value.

    Measured: 30 days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start1 Apr 2020
  3. Primary completionAug 2020 (estimated)
  4. Study completionAug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of aspirin 100 mg once daily, atorvastatin 20 mg once daily, vitamin B12 100 mg three times daily (control group) or standard therapy and DLBS1033 3 times daily (experimental group).
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04425590
Sponsor's protocol ID
INADLBS
Status last verified
Jun 2020
First submitted
27 May 2020
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krishnamurthi RV, Feigin VL, Forouzanfar MH, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson LM, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, Risk Factors Study 2010 (GBD 2010); GBD Stroke Experts Group. Global and regional burden of first-ever ischaemic and haemorrhagic stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet Glob Health. 2013 Nov;1(5):e259-81. doi: 10.1016/S2214-109X(13)70089-5. Epub 2013 Oct 24.

    PubMed 25104492

  • Mellor RM, Bailey S, Sheppard J, Carr P, Quinn T, Boyal A, Sandler D, Sims DG, Mant J, Greenfield S, McManus RJ. Decisions and delays within stroke patients' route to the hospital: a qualitative study. Ann Emerg Med. 2015 Mar;65(3):279-287.e3. doi: 10.1016/j.annemergmed.2014.10.018. Epub 2014 Nov 15.

    PubMed 25455907

  • Ogbole GI, Owolabi MO, Ogun O, Ogunseyinde OA, Ogunniyi A. TIME OF PRESENTATION OF STROKE PATIENTS FOR CT IMAGING IN A NIGERIAN TERTIARY HOSPITAL. Ann Ib Postgrad Med. 2015 Jun;13(1):23-8.

    PubMed 26807083

  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PubMed 23652265

  • Tjandrawinata RR, Trisina J, Rahayu P, Prasetya LA, Hanafiah A, Rachmawati H. Bioactive protein fraction DLBS1033 containing lumbrokinase isolated from Lumbricus rubellus: ex vivo, in vivo, and pharmaceutic studies. Drug Des Devel Ther. 2014 Sep 25;8:1585-93. doi: 10.2147/DDDT.S66007. eCollection 2014.

    PubMed 25284988

  • Toyoda K. Epidemiology and registry studies of stroke in Japan. J Stroke. 2013 Jan;15(1):21-6. doi: 10.5853/jos.2013.15.1.21. Epub 2013 Jan 31.

    PubMed 24324936

  • Trisina J, Sunardi F, Suhartono MT, Tjandrawinata RR. DLBS1033, a protein extract from Lumbricus rubellus, possesses antithrombotic and thrombolytic activities. J Biomed Biotechnol. 2011;2011:519652. doi: 10.1155/2011/519652. Epub 2011 Mar 3.

    PubMed 21403877

  • Venketasubramanian N, Yoon BW, Pandian J, Navarro JC. Stroke Epidemiology in South, East, and South-East Asia: A Review. J Stroke. 2017 Sep;19(3):286-294. doi: 10.5853/jos.2017.00234. Epub 2017 Sep 29.

    PubMed 29037005

  • Zhou M, Offer A, Yang G, Smith M, Hui G, Whitlock G, Collins R, Huang Z, Peto R, Chen Z. Body mass index, blood pressure, and mortality from stroke: a nationally representative prospective study of 212,000 Chinese men. Stroke. 2008 Mar;39(3):753-9. doi: 10.1161/STROKEAHA.107.495374. Epub 2008 Jan 31.

    PubMed 18239175

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DLBS1033, Aspirin and Statin in people with Ischemic Stroke, run by Duta Wacana Christian University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rizaldy T Pinzon, MD, MSc, PhD (+62 81294638229, drpinzon17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in modified Rankin Scale (mRS) scores at hospital discharge (time frame: At hospital discharge (approximately 4 days after treatment initiation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04425590, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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