NCT07121569CompletedPhase 4
Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: Impact on Inflammatory Biomarkers and Outcomes
Efficacy of Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: A Randomized Controlled Trial Evaluating Inflammatory Biomarkers, TCD Results, and Clinical Outcomes
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 6 Aug 2025
- Start date
- 6 Jul 2024
- Primary completion date
- 4 Mar 2025
- Lead sponsor
- Universitas Sebelas Maret
- Diseases
- Stroke
- NCT number
- NCT07121569
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 52
- From 6 Jul 2024 to the primary completion date, 4 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hemorrhagic stroke within the last 3 months.
- Having or History of bleeding disorders or coagulopathy.
- History of autoimmune disease.
- Acute infection (systemic inflammatory response syndrome).
- Hypersensitivity to DLBS1033
Lab values
- Severe renal impairment (serum creatinine ≥3× normal or on hemodialysis).
Other
- Transient ischemic attack.
- Pregnant, breastfeeding, or planning pregnancy.
- Use of anticoagulants in the past month.
- Nasogastric tube feeding.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Moewardi Regional General Hospital Coordinator of this site? Confirm its status | Surakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.