- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425590
The Benefit of Add On DLBS1033 for Ischemic Stroke Patient
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
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Vanessa Veronica
- Phone Number: +62 89605559529
- Email: vanessaveronica73@gmail.com
Study Locations
-
-
Special Region Of Yogyakarta
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Yogyakarta, Special Region Of Yogyakarta, Indonesia, 55224
- Recruiting
- Bethesda Hospital Yogyakarta
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
|
DLBS 1033 490 mg tablet 3 times daily
Other Names:
Aspirin 100 mg tablet once daily
Atorvastatin 20 mg tablet once daily
Other Names:
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
|
Aspirin 100 mg tablet once daily
Atorvastatin 20 mg tablet once daily
Other Names:
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Rizaldy Pinzon, MD, MSc, PhD, Duta Wacana Christian University
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: J Stroke. 2018 Jan;20(1):142.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Aspirin
- Atorvastatin
Other Study ID Numbers
- INADLBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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