A Phase 4 interventional study of Oral lumbrokinase DLBS1033 and Placebo in Ischemic Stroke, Acute, sponsored by Universitas Sebelas Maret. Completed at 1 site in Indonesia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Universitas Sebelas Maret · Phase 4, Interventional, and Treatment
This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of oral DLBS1033 as adjunctive therapy on inflammatory biomarkers (IL-6, TNF-α, MMP-9, D-dimer), transcranial Doppler (TCD) parameters, and clinical outcomes in patients with acute ischemic stroke. Fifty-two eligible patients admitted to RSUD Dr. Moewardi Surakarta will be randomly assigned to receive either DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) or placebo for 28 days, in addition to standard therapy between July 2024 to March 2025. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, following full ethical approval from the hospital's Health Research Ethics Committee. Primary outcomes include changes in inflammatory markers; secondary outcomes include changes in NIHSS and Barthel Index scores and TCD profiles.
Intravenous thrombolysis with tissue plasminogen activator (tPA) or mechanical thrombectomy is considered first-line treatment to mediate reperfusion. Despite the rapid restoration of cerebral blood flow post-stroke, recanalization of occluded vessels can lead to progressive tissue damage, a condition known as ischemia-reperfusion injury. Reperfusion triggers a strong inflammatory response, supporting the development of a thrombo-inflammatory cascade. Previous studies have shown that lumbrokinase, a component of DLBS1033, plays a role in modulating the inflammatory cascade. Lumbrokinase has been shown to significantly reduce several inflammatory biomarkers, such as IL-6, TNF-alpha, and MMP-9, in an animal study level. However, no studies have yet examined the role of lumbrokinase in reducing TNF-α, MMP-9, and IL-6 levels in the blood of patients with ischemic stroke. Previous studies stated that administration of DLBS1033 significantly improves clinical outcomes in ischemic stroke patients, as measured by NIHSS and Barthel Index scores. Based on this background, the researcher is interested in investigating the effect of oral DLBS1033 as adjunctive therapy on the thrombo-inflammatory patho-mechanism in patients with ischemic stroke, as assessed by inflammatory biomarkers, TCD parameters, and clinical outcomes.
Eligible patients diagnosed with acute ischemic stroke, presenting within a time window of 24 hours to 7 days from symptom onset, will be enrolled and randomly assigned into two parallel groups in a 1:1 ratio. The diagnosis of ischemic stroke was made based on physical examination and confirmed by a non-contrast head CT scan performed by a neurologist. One group will receive oral DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.), while the other will receive a matching placebo. Both interventions will be administered alongside standard stroke treatment protocols for a duration of 28 days. Randomization will be stratified to ensure balanced baseline characteristics between groups. Random allocation sequences were prepared by independent team and secured in sealed envelope. Each treatment package was pre-labeled with a unique subject identification number that corresponded to the assigned number in the randomization sequence. Upon enrollment, eligible participants received the treatment package that matched their assigned number.
Throughout the study, several key parameters will be assessed to evaluate the efficacy and safety of DLBS1033 as an adjunctive therapy. These include inflammatory biomarkers, such as serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), matrix metalloproteinase-9 (MMP-9), and D-dimer, which will be measured using validated immunoassay methods. In addition, cerebral hemodynamic status will be evaluated through Transcranial Doppler (TCD) ultrasonography to assess Pulsatility Index (PI), and carotid intima-media thickness (CIMT) will be measured via B-mode ultrasonography to examine vascular structural changes.
To evaluate clinical outcomes, the National Institutes of Health Stroke Scale (NIHSS) will be used to assess neurological deficits, and the Barthel Index will be used to evaluate functional independence in daily activities. All assessments, including laboratory biomarker tests, TCD and CIMT measurements, and clinical outcome scoring, will be conducted at three key time points: baseline, day 14, and day 28 post-initiation of therapy.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 52 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
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Exclusion Criteria:
Patients with acute ischemic stroke who received oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period
Drug: Oral lumbrokinase DLBS1033
Patients with acute ischemic stroke who received placebo (Placebo by Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period
Drug: Placebo
DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d
Also known as: DISOLF
Placebo by Dexa Medica, 2 tabs t.i.d.
MMP-9
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Time frame: Baseline, day 14 and 28
IL-6
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Time frame: Baseline, day 14 and 28
TNF-alpha
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Time frame: Baseline, day 14 and 28
d-dimer
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Time frame: Baseline, day 14 and 28
TCD parameter-CIMT
Measurement of carotid intima-media thickness using TCD examination of the CCA was performed on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28. CIMT values fall within a positive range, greater than 0, where higher values indicate a possible thickening of the blood vessels, as a sign of atherosclerosis
Time frame: Baseline, day 14 and 28
TCD parameter-PI
Measurement of the pulsatility index using TCD examination of the CCA, ICA, vertebral artery, MCA, ACA, PCA, and ROA was conducted on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28. PI values fall within a positive range, greater than 0, where higher values indicate greater vascular resistance.
Time frame: Baseline, day 14 and 28
NIHSS
Assessment of stroke severity was conducted by evaluating various neurological functions, including consciousness, gaze, visual field, facial palsy, extrimity function, ataxia, sensory, language, dysarthria, and aphasia. This assessment was performed before the patient received therapy and after the patient had undergone therapy for 14 and 28 days. Minimum score is 0 and maximum score is 42, where a higher NIHSS score indicates a more severe degree of stroke.
Time frame: Baseline, day 14 and 28
Barthel Index
Assessment of the ability to perform activities of daily living, such as eating, drinking, self-care, mobility, using the toilet, moving around, climbing stairs, dressing, and bladder and bowel control, was conducted before the patient received therapy and after the patient had undergone therapy for 14 and 28 days. Minimum score is 0 and maximum score is 100, where a higher Barthel Index score indicates better patient ADL function.
Time frame: Baseline, day 14 and 28
Plan to share: Yes — Publication in ICMJE journals
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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