Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: Impact on Inflammatory Biomarkers and Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-06

Study Completion Date

2025-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized, double-masked controlled trial employed a rigorous experimental design to compare the adjunctive therapeutic effects of oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) versus placebo in patients with acute ischemic stroke over a 28-day prospective observation period. 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, Indonesia, from July 2024 to March 2025, after obtaining full ethical clearance from the hospital's Health Research Ethics Committee

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The study utilized a two-block randomization method to achieve balanced group assignments. Random allocation sequences were prepared by independent personnel and secured in sealed envelope. Each treatment package was labeled with a subject identification number corresponding to the generated random sequence and was distributed to eligible participants. The codes were kept confidential until the study was completed

Study Groups

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Oral lumbrokinase DLBS1033 group

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

Group Type EXPERIMENTAL

Oral lumbrokinase DLBS1033

Intervention Type DRUG

DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d

Placebo group

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo by Dexa Medica, 2 tabs t.i.d.

Interventions

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Oral lumbrokinase DLBS1033

DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d

Intervention Type DRUG

Placebo

Placebo by Dexa Medica, 2 tabs t.i.d.

Intervention Type DRUG

Other Intervention Names

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DISOLF

Eligibility Criteria

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Inclusion Criteria

* Inpatient with acute ischemic stroke onset 24 hours-7 days confirmed by CT scan.
* First-ever or recurrent ischemic stroke.
* Compos mentis on admission.
* NIHSS score 5-25 on admission.
* Willing to participate and signed informed consent

Exclusion Criteria

* Hemorrhagic stroke within the last 3 months.
* Transient ischemic attack.
* Pregnant, breastfeeding, or planning pregnancy.
* Use of anticoagulants in the past month.
* Nasogastric tube feeding.
* Having or History of bleeding disorders or coagulopathy.
* History of autoimmune disease.
* Severe renal impairment (serum creatinine ≥3× normal or on hemodialysis).
* Acute infection (systemic inflammatory response syndrome).
* Hypersensitivity to DLBS1033

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No