CompletedPhase 4

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

Indonesia44 participantsStarted 2024-04-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Dizziness severity

Timeframe: baseline, day 7, and day 14

Quality of life from the BPPV patients

Timeframe: baseline, day 7, and day 14

Inflammatory biomarkers of the BPPV patients

Timeframe: baseline, day 7, and day 14

Trial details

NCT IDNCT07075289

SponsorUniversitas Sebelas Maret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Benign Paroxysmal Positional Vertigo (Disorder) trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.