The Benefit of Add On DLBS1033 for Ischemic Stroke Patient

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425590
• Other study ID #: INADLBS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2020
• Est. completion date: August 2020

Study information

• Verified date: June 2020
• Source: Duta Wacana Christian University
• Contact: Rizaldy T Pinzon, MD, MSc, PhD
• Phone: +62 81294638229
• Email: drpinzon17[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• DLBS1033
DLBS 1033 490 mg tablet 3 times daily
• Aspirin
Aspirin 100 mg tablet once daily
• Statin
Atorvastatin 20 mg tablet once daily
• Vit B12
Vit B12 100 mg tablet three times daily

Locations

Country	Name	City	State
Indonesia	Bethesda Hospital Yogyakarta	Yogyakarta	Special Region Of Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Duta Wacana Christian University	Dexa Laboratories Of Biomolecular Science

Country where clinical trial is conducted

Indonesia, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Stroke. 2019 Aug;50(8):e239. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. Erratum in: J Stroke. 2018 Jan;20(1):142. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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