Dataset of Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: Impact on Inflammatory Biomarkers and Outcomes
Description
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.
Files
Steps to reproduce
This research was already registered at at ClinicalTrials.gov under number NCT07121569.