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

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.

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