Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo
Other study identifiers
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Dexa Medica
interventional
44
1 country
1
Study Start
April 1, 2024
Actual (reported)Primary Completion
August 31, 2024
Actual (reported)Study Completion
December 27, 2024
Actual (reported)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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 44 participants
- Study completion date
December 27, 2024
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
April 1, 2024
Actual (reported)Primary Completion
August 31, 2024
Actual (reported)Study Completion
December 27, 2024
Actual (reported)First Submitted
July 1, 2025
Actual (reported)First Posted
July 20, 2025
Actual (reported)
- Last Updated
- July 20, 2025
- Status Verified
- July 2025
- Last Update Submitted
- July 10, 2025