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

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)

Interventions

DRUG

DLBS1033

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

DRUG

Betahistine Mesylate tablet

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

Sponsors & Collaborators

• Dexa Medica Group

  collaborator INDUSTRY

• Universitas Sebelas Maret

  lead OTHER

Principal Investigators

• Stefanus E Putra, MD · Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2024-08-31

Completion

2024-12-27

Countries

• Indonesia

Study Locations