Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo

NCT07075289 | Completed Phase 4 DMC

• 2 other identifiers: 623/II/HREC/2024UST-002.24/DLBS1033/1/2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if oral lumbrokinase DLBS1033 works better than betahistine mesylate on inflammation, quality of life, and dizziness symptoms of adult benign paroxysmal positional vertigo (BPPV) patients. It will also learn about the safety of oral lumbrokinase DLBS1033 as a causative therapy of BPPV. The main questions it aims to answer are:

• Is there a difference in the decrease in IL-1β levels between BPPV patients who receive oral lumbrokinase DLBS1033 therapy and patients who receive betahistine mesylate therapy?
• Is there a difference in the decrease in TNF-α levels between BPPV patients who receive oral lumbrokinase DLBS1033 therapy and patients who receive betahistine mesylate therapy?
• Is there a difference in the decrease in VCAM-1 levels between BPPV patients who receive oral lumbrokinase DLBS1033 therapy and patients who receive betahistine mesylate therapy?
• Is there a difference in the quality of life between BPPV patients who receive oral lumbrokinase DLBS1033 therapy and patients who receive betahistine mesylate therapy?
• Is there a difference in the time to improve dizziness symptoms between BPPV patients who receive oral lumbrokinase DLBS1033 therapy and patients who receive betahistine mesylate therapy? Researchers will compare oral lumbrokinase DLBS1033 to betahistine mesylate to see if oral lumbrokinase DLBS1033 works better to treat BPPV Participants will:
• Join a brief interview to find out the current and past medical history, as well as a physical examination of the study participants
• Give blood samples for biomarker examination, which will be conducted at the Clinical Pathology Laboratory of Dr. Moewardi Surakarta Hospital
• Take oral lumbrokinase DLBS1033 or betahistine mesylate every day for 2 weeks
• Visit the clinic once every week for evaluation and the blood test
• Keep a diary of their symptoms

Conditions

Benign Paroxysmal Positional Vertigo (Disorder)

Keywords

benign paroxysmal positional vertigo (BPPV); betahistine mesylate; dizziness; inflammation; oral lumbrokinase DLBS1033; quality of life

Outcome Measures

Primary Outcomes (3)

• Dizziness severity

  The total value obtained from filling in the Indonesian version of the Vertigo Symtom Scale-Short Version (VSS-SF) in BPPV patients which can reflect the severity of dizziness symptoms (floating, swinging or shifting sensations) in patients.

  baseline, day 7, and day 14

• Quality of life from the BPPV patients

  The total value obtained from filling in the Dizziness Handicap Inventory (DHI) questionnaire in BPPV patients which can reflect the impact of dizziness on the physical, emotional and functional aspects of the patient's daily life.

  baseline, day 7, and day 14

• Inflammatory biomarkers of the BPPV patients

  TNF-α, IL-1β, and VCAM-1 levels as pro-inflammatory biomarkers were measured before patients received therapy, on the 7th day after receiving therapy, and on the 14th day after patients received therapy.

  baseline, day 7, and day 14

Study Arms (2)

Oral lumbrokinase DLBS1033 group

EXPERIMENTAL

BPPV patients who got oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) for 14-day prospective observation period.

Drug: DLBS1033

Betahistine mesylate group

ACTIVE COMPARATOR

BPPV patients who got betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) for 14-day prospective observation period.

Drug: Betahistine Mesylate tablet

Interventions

DLBS1033 DRUG

Participants would get oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period.

Oral lumbrokinase DLBS1033 group

Betahistine Mesylate tablet DRUG

Patients would get betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period.

Betahistine mesylate group

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 65 years old
• Diagnosed with BPPV by a neurologist based on a clear history of positional vertigo symptoms (nausea, vomiting, imbalance with head movements) and characteristic torsional nystagmus during the Dix-Hallpike maneuver (latency, fatigability, duration less than 60 seconds)
• Proficient in Indonesian
• Provided informed consent

You may not qualify if:

• Pregnant or breastfeeding
• Showed signs of central vertigo or other neurological deficits
• Had current ear infections, hearing impairment, tinnitus, head trauma, or underlying conditions such as thyroid disorders, diabetes mellitus, osteoarthritis, a history of neoplasm, cardiovascular disease, hypertension, or recent ear/mastoid surgery.
• Cognitive impairment
• Participation in other clinical trials within 30 days prior to screening

Sponsors & Collaborators

• Universitas Sebelas Maret: lead
• Dexa Medica Group: collaborator

Study Sites (1)

Dr. Moewardi Regional General Hospital

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (3)

• Walther LE, Wenzel A, Buder J, Bloching MB, Kniep R, Blodow A. Detection of human utricular otoconia degeneration in vital specimen and implications for benign paroxysmal positional vertigo. Eur Arch Otorhinolaryngol. 2014 Dec;271(12):3133-8. doi: 10.1007/s00405-013-2784-6. Epub 2013 Oct 30.

  PMID: 24170182 BACKGROUND

• Tang Y, Zhou X, Cao T, Chen E, Li Y, Lei W, Hu Y, He B, Liu S. Endoplasmic Reticulum Stress and Oxidative Stress in Inflammatory Diseases. DNA Cell Biol. 2022 Nov;41(11):924-934. doi: 10.1089/dna.2022.0353. Epub 2022 Sep 14.

  PMID: 36356165 BACKGROUND

• Bashiruddin J, Alviandi W, Branantyo B, Daneswarry D. 2019. Validitas, reliabilitas dan adaptasi transkultural Dizziness Handicap Inventory dalam bahasa Indonesia. Oto Rhino Laryngologica Indonesiana. 49(2), 162-3. https://doi.org/10.32637/orli.v49i20.318.

  BACKGROUND

Related Links

• Study protocol

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Dizziness; Inflammation

Interventions

DLBS 1033; Betahistine

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stefanus E Putra, 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 protocol involved a two-block randomization to ensure balanced group assignments. The random sequences for the group allocation were generated by independent personnel of the direct study management and kept in sealed envelopes. This allocation concealment ensured that neither the investigator team nor the participants knew their assigned treatment. Each package was coded with the subject identification number according to the generated random number and assigned to each eligible subject. These codes remained unrevealed until the study's completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Neurologist)

Model Details: This study was designed as a randomized controlled double-masked trial, representing a robust experimental approach to compare the therapeutic effects of oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) and betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) in patients suffering from BPPV for a 14-day prospective observation period. The research was carried out at the Neurology Outpatient Clinic of Dr. Moewardi General Hospital in Surakarta, Central Java, Indonesia, between April and August 2024, following full ethical approval from the hospital's Health Research Ethics Committee.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 27, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: July 1st, 2025-July 1st, 2026
• Access Criteria: Open access, every journal visitor

Locations

ID (1)