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

NCT07121569 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Ischemic Stroke, Acute

Interventions

DRUG

Oral lumbrokinase DLBS1033

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Universitas Sebelas Maret

    lead OTHER

Principal Investigators

  • Firstiafina Tiffany, MD · Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-06
Primary Completion
2025-03-04
Completion
2025-03-13

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121569 on ClinicalTrials.gov