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

NCT07121569 | Completed Phase 4 DMC

• 2 other identifiers: DLBS1033 on Ischemic StrokeUST-003.24/DLBS1033/1/2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Interleukin-6; Ischemic Stroke; Treatment outcome; Tumor Necrosis Factor-alpha; Oral lumbrokinase DLBS1033

Outcome Measures

Primary Outcomes (4)

• MMP-9

  The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28

  Baseline, day 14 and 28

• IL-6

  The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28

  Baseline, day 14 and 28

• TNF-alpha

  The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28

  Baseline, day 14 and 28

• d-dimer

  The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28

  Baseline, day 14 and 28

Secondary Outcomes (4)

• TCD parameter-CIMT

  Baseline, day 14 and 28

• TCD parameter-PI

  Baseline, day 14 and 28

• NIHSS

  Baseline, day 14 and 28

• Barthel Index

  Baseline, day 14 and 28

Study Arms (2)

Oral lumbrokinase DLBS1033 group

EXPERIMENTAL

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

Drug: Oral lumbrokinase DLBS1033

Placebo group

ACTIVE COMPARATOR

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

Drug: Placebo

Interventions

Oral lumbrokinase DLBS1033 DRUG

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

Also known as: DISOLF

Oral lumbrokinase DLBS1033 group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Dr. Moewardi Regional General Hospital

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (2)

• Pinzon RT, Tjandrawinata RR, Wijaya VO, Veronica V. Effect of DLBS1033 on Functional Outcomes for Patients with Acute Ischemic Stroke: A Randomized Controlled Trial. Stroke Res Treat. 2021 Apr 7;2021:5541616. doi: 10.1155/2021/5541616. eCollection 2021.

  PMID: 33927846 BACKGROUND

• Wang WL, Hsu YM, Lin ML, Chen SS, Lai YH, Huang CH, Yao CH. Ex Vivo Model to Evaluate the Antibacterial and Anti-Inflammatory Effects of Gelatin-Tricalcium Phosphate Composite Incorporated with Emodin and Lumbrokinase for Bone Regeneration. Bioengineering (Basel). 2023 Jul 31;10(8):906. doi: 10.3390/bioengineering10080906.

  PMID: 37627791 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Firstiafina Tiffany, MD

  Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Neurologist)

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: July 6, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 13, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: August 6th, 2025-August 6th, 2026
• Access Criteria: Open access, every journal visitor

Locations

ID (1)