The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

NCT04425590 | Unknown Phase 2

• 1 other identifier: INADLBS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Ischemic Stroke

Keywords

DLBS1033; Standard therapy; Stroke; Outcomes; Lumbrokinase

Outcome Measures

Primary Outcomes (6)

• 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.

  At hospital discharge (approximately 4 days after treatment initiation)

• 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.

  30 days after treatment initiation

• 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.

  At hospital discharge (approximately 4 days after treatment initiation)

• 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.

  30 days after treatment initiation

• Improvement in Barthel Index (BI) scores at hospital discharge

  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

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

  30 days after treatment initiation

Study Arms (2)

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).

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

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

Drug: Aspirin; Drug: Statin; Drug: Vit B12

Interventions

DLBS1033 DRUG

DLBS 1033 490 mg tablet 3 times daily

Also known as: Disolf

Experimental Group

Aspirin DRUG

Aspirin 100 mg tablet once daily

Control Group; Experimental Group

Statin DRUG

Atorvastatin 20 mg tablet once daily

Also known as: Atorvastatin

Control Group; Experimental Group

Vit B12 DRUG

Vit B12 100 mg tablet three times daily

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duta Wacana Christian University: lead
• Dexa Laboratories Of Biomolecular Science: collaborator

Study Sites (1)

Bethesda Hospital Yogyakarta

Yogyakarta, Special Region of Yogyakarta, 55224, Indonesia

RECRUITING

Related Publications (9)

• 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.

  PMID: 25104492 BACKGROUND

• 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.

  PMID: 25455907 BACKGROUND

• 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.

  PMID: 26807083 BACKGROUND

• 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.

  PMID: 23652265 BACKGROUND

• 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.

  PMID: 25284988 BACKGROUND

• 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.

  PMID: 24324936 BACKGROUND

• 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.

  PMID: 21403877 BACKGROUND

• 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.

  PMID: 29037005 BACKGROUND

• 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.

  PMID: 18239175 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

DLBS 1033; Aspirin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Vitamin B 12

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Corrinoids; Tetrapyrroles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Rizaldy Pinzon, MD, MSc, PhD

  Duta Wacana Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rizaldy T Pinzon, MD, MSc, PhD

CONTACT

+62 81294638229; drpinzon17@gmail.com

Vanessa Veronica

CONTACT

+62 89605559529; vanessaveronica73@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Neurologist

Model Details: 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).

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 11, 2020
• Study Start: April 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)