Benign Paroxysmal Positional Vertigo (Disorder)Phase 4NCT07075289
Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo
A Phase 4 study testing DLBS1033 and Betahistine Mesylate tablet in people with Benign Paroxysmal Positional Vertigo (Disorder), run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (Disorder)
- What is being tested?
- DLBS1033 and Betahistine Mesylate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2024to 27 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi Regional General Hospital
Surakarta, Central Java, 57126
About this study
Official title: Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo: A Randomized Comparative Study on Inflammatory Markers, Quality of Life, and Symptom Resolution
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
Read more
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
Read the detailed description
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.
The study population comprised patients attending the aforementioned clinic, with specific inclusion and exclusion criteria applied to select eligible subjects via a purposive sampling method. Included patients were 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). Furthermore, participants had to be proficient in Indonesian and provide informed consent. Patients were excluded if they were 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 and participation in other clinical trials within 30 days prior to screening were also grounds for exclusion. To ensure data integrity, dropout criteria were established for patients unable to complete the study protocol, those who did not adhere to procedures, or those failing to complete the necessary questionnaires.
A total of 44 participants were enrolled, determined by a sample size calculation based on a 95% confidence interval and 5% confidence limits, with an additional 10% allowance for potential dropouts from a previous year's patient population of 751 peripheral vertigo cases. Standardized instruments were utilized for data collection, including the Indonesian version of Dizziness Handicap Inventory (DHI) for assessing quality of life which categorize it as poor, moderate, or good based on physical, emotional, and functional aspects; and the Indonesian version of the Vertigo Symptom Scale-Short Form (VSS-SF) to evaluate dizziness symptom severity, which is categorized as severe or low [15]. Furthermore, concentrations of key inflammatory biomarkers, specifically TNF-α, IL-1β, and VCAM-1, were quantified using Human Quantikine R\&D Systems kits on a Thermo Fisher Invitrogen auto-analyzer according to manufacturer specifications.
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. The investigator team members, assigned as the enumerators, conducted symptom and quality of life assessments using the DHI and VSS-SF on the first day (baseline), seventh day, and fourteenth day after treatment initiation. Concurrently, blood samples were collected to assess TNF-α, IL-1β, and VCAM-1 levels. All collected data were then compiled and statistically analyzed using SPSS for Windows 25.0. Before hypothesis testing, data completeness and accuracy were verified, followed by coding, tabulation, and entry into the software. Normality of data distribution was assessed using the Kolmogorov-Smirnov test. Independent T-tests were performed for normally distributed data. Multiple linear regression analysis was conducted to investigate the relationship between inflammatory markers, quality of life, and potential confounding variables, and ordinal logistic regression analysis was conducted to determine the odds ratios (ORs) for inflammation levels and quality of life.
- Being tested
- DLBS1033, Betahistine Mesylate tablet
- Keywords
- benign paroxysmal positional vertigo (BPPV), betahistine mesylate, dizziness, inflammation, oral lumbrokinase DLBS1033, quality of life
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Dizziness, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1033Drug
Participants would get oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period.
Betahistine Mesylate tabletDrug
Patients would get betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Betahistine Mesylate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline, day 7, and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Apr 2024
- Primary completion31 Aug 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional Vertigo (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Collaborators
- Dexa Medica Group
- Responsible party
- Principal investigator, Stefanus Erdana Putra, Universitas Sebelas Maret
- Investigators
- Stefanus E Putra, MD, Principal investigator, Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075289
- Sponsor's protocol ID
- 623/II/HREC/2024
- Other IDs
- UST-002.24/DLBS1033/1/2024
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in ICMJE journals
Publications
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.
PubMed 24170182Tang 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.
PubMed 36356165Bashiruddin 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Oral Lumbrokinase DLBS1033 and Betahistine Mesylate in Benign Paroxysmal Positional Vertigo: A Randomized Comparative Study on Inflammatory Markers, Quality of Life, and Symptom Resolution
- ClinicalTrials.gov ID
- NCT07075289
- Acronym / sponsor ID
- 623/II/HREC/2024
- Keywords
- benign paroxysmal positional vertigo (BPPV), betahistine mesylate, dizziness, inflammation, oral lumbrokinase DLBS1033, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Collaborators
- Dexa Medica Group
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
The study population comprised patients attending the aforementioned clinic, with specific inclusion and exclusion criteria applied to select eligible subjects via a purposive sampling method. Included patients were 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). Furthermore, participants had to be proficient in Indonesian and provide informed consent. Patients were excluded if they were 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 and participation in other clinical trials within 30 days prior to screening were also grounds for exclusion. To ensure data integrity, dropout criteria were established for patients unable to complete the study protocol, those who did not adhere to procedures, or those failing to complete the necessary questionnaires.
A total of 44 participants were enrolled, determined by a sample size calculation based on a 95% confidence interval and 5% confidence limits, with an additional 10% allowance for potential dropouts from a previous year's patient population of 751 peripheral vertigo cases. Standardized instruments were utilized for data collection, including the Indonesian version of Dizziness Handicap Inventory (DHI) for assessing quality of life which categorize it as poor, moderate, or good based on physical, emotional, and functional aspects; and the Indonesian version of the Vertigo Symptom Scale-Short Form (VSS-SF) to evaluate dizziness symptom severity, which is categorized as severe or low [15]. Furthermore, concentrations of key inflammatory biomarkers, specifically TNF-α, IL-1β, and VCAM-1, were quantified using Human Quantikine R\&D Systems kits on a Thermo Fisher Invitrogen auto-analyzer according to manufacturer specifications.
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. The investigator team members, assigned as the enumerators, conducted symptom and quality of life assessments using the DHI and VSS-SF on the first day (baseline), seventh day, and fourteenth day after treatment initiation. Concurrently, blood samples were collected to assess TNF-α, IL-1β, and VCAM-1 levels. All collected data were then compiled and statistically analyzed using SPSS for Windows 25.0. Before hypothesis testing, data completeness and accuracy were verified, followed by coding, tabulation, and entry into the software. Normality of data distribution was assessed using the Kolmogorov-Smirnov test. Independent T-tests were performed for normally distributed data. Multiple linear regression analysis was conducted to investigate the relationship between inflammatory markers, quality of life, and potential confounding variables, and ordinal logistic regression analysis was conducted to determine the odds ratios (ORs) for inflammation levels and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral lumbrokinase DLBS1033 group | Experimental | Drug: DLBS1033BPPV patients who got oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) for 14-day prospective observation period. |
| Betahistine mesylate group | Active comparator | Drug: Betahistine Mesylate tabletBPPV patients who got betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) for 14-day prospective observation period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS1033Participants would get oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period. | Drug | Oral lumbrokinase DLBS1033 group |
| Betahistine Mesylate tabletPatients would get betahistine mesylate (12 mg, MERTIGO SR tablet, Dexa Medica b.i.d.) for a 14-day prospective observation period. | Drug | Betahistine mesylate group |
Primary outcome
Dizziness severity
Time frame: baseline, day 7, and day 14
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.
Quality of life from the BPPV patients
Time frame: baseline, day 7, and day 14
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.
Inflammatory biomarkers of the BPPV patients
Time frame: baseline, day 7, and day 14
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 24170182Walther 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.
- Background: PubMed 36356165Tang 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.
- BackgroundBashiruddin 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.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication in ICMJE journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanus E Putra, MD principal investigator
Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DLBS1033 and Betahistine Mesylate tablet in people with Benign Paroxysmal Positional Vertigo (Disorder), run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness severity (time frame: baseline, day 7, and day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075289, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.