Peripheral VertigoNCT05676216
Sodium Bicarbonate for Acute Peripheral Vertigo
A study testing Diphenhydramine, Sodium Bicarbonate and Diphenhydramine + Sodium Bicarbonate in people with Peripheral Vertigo, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vertigo
- What is being tested?
- Diphenhydramine, Sodium Bicarbonate and Diphenhydramine + Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute onset vertigo
Who cannot join
- Pregnancy
- First vertigo episode over 24 hours
- Using any anti-vertigo medicine after onset
- Drug allergy to Sodium bicarbonate or Diphenhydramine
- Diagnosed with central vertigo
- Heart failure NYHA class >1
- Chronic kidney disease (CKD) stage ≥ 3
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Yunlin Branch
Yunlin County
Chien-Yu Chi, MD, +886 0972655833, Y06108@ms1.ylh.gov.tw
About this study
Official title: Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial
Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED.
Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling.
Read more
Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication.
This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.
- Conditions
- Peripheral Vertigo
- Being tested
- Diphenhydramine, Sodium Bicarbonate, Diphenhydramine + Sodium Bicarbonate
- Keywords
- Sodium Bicarbonate, Diphenhydramine
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydramineDrug
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Sodium BicarbonateDrug
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Diphenhydramine + Sodium BicarbonateDrug
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department
| Study group | Role | What they receive |
|---|---|---|
| Diphenhydramine | Active comparator | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping Receives: Drug: Diphenhydramine |
| Sodium Bicarbonate | Experimental | Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping Receives: Drug: Sodium Bicarbonate |
| Diphenhydramine with Sodium Bicarbonate | Experimental | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push Receives: Drug: Diphenhydramine + Sodium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in vertigo intensity
Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
Measured: Baseline and 60 minutes after drug administration
Secondary outcomes (4)
Reduction in nausea intensity
Reduction in Nausea Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
Measured: Baseline and 60 minutes after drug administration
Improvement of ambulatory ability
Change in objective ambulatory ability (score 1~4, higher scores mean a worse outcome) from baseline
Measured: Baseline and 60 minutes after drug administration
Lethargy
Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy)
Measured: 60 minutes after drug administration
Emergency Department staying time
From patients admit to Emergency Department until patients discharge (up to 24 hours)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start7 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Peripheral VertigoStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Yu Chi, MD, Principal investigator, Emergency Department, National Taiwan University, Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676216
- Sponsor's protocol ID
- 202209092MIND
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunter BR, Wang AZ, Bucca AW, Musey PI Jr, Strachan CC, Roumpf SK, Propst SL, Croft A, Menard LM, Kirschner JM. Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Sep 1;79(9):846-855. doi: 10.1001/jamaneurol.2022.1858.
PubMed 35849408Numata K, Shiga T, Omura K, Umibe A, Hiraoka E, Yamanaka S, Azuma H, Yamada Y, Kobayashi D. Comparison of acute vertigo diagnosis and treatment practices between otolaryngologists and non-otolaryngologists: A multicenter scenario-based survey. PLoS One. 2019 Mar 7;14(3):e0213196. doi: 10.1371/journal.pone.0213196. eCollection 2019.
PubMed 30845218Chi CY, Chen YC, Cheng MT, Chang KC, Chen YP, Tsai MS, Chang WT, Ma MH, Huang CH, Chiang WC. Diphenhydramine, Sodium Bicarbonate, or Combination for Acute Peripheral Vertigo: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2541472. doi: 10.1001/jamanetworkopen.2025.41472.
PubMed 41196596
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05676216
- Acronym / sponsor ID
- 202209092MIND
- Conditions
- Peripheral Vertigo
- Keywords
- Sodium Bicarbonate, Diphenhydramine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jan 2023 (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.
Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED.
Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling.
Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication.
This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diphenhydramine | Active comparator | Drug: DiphenhydramineDiphenhydramine 30 mg in 100 mL normal saline intravenous dripping |
| Sodium Bicarbonate | Experimental | Drug: Sodium BicarbonateSodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping |
| Diphenhydramine with Sodium Bicarbonate | Experimental | Drug: Diphenhydramine + Sodium BicarbonateDiphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute onset vertigo
Key exclusion criteria (7 listed)
- Pregnancy
- First vertigo episode over 24 hours
- Using any anti-vertigo medicine after onset
- Drug allergy to Sodium bicarbonate or Diphenhydramine
- Diagnosed with central vertigo
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 |
|---|---|---|
| DiphenhydramineDiphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department | Drug | Diphenhydramine |
| Sodium BicarbonateSodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department | Drug | Sodium Bicarbonate |
| Diphenhydramine + Sodium BicarbonateDiphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department | Drug | Diphenhydramine with Sodium Bicarbonate |
Primary outcome
Reduction in vertigo intensity
Time frame: Baseline and 60 minutes after drug administration
Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
4 secondary outcomes
Reduction in nausea intensity
Time frame: Baseline and 60 minutes after drug administration
Improvement of ambulatory ability
Time frame: Baseline and 60 minutes after drug administration
Lethargy
Time frame: 60 minutes after drug administration
Emergency Department staying time
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 35849408Hunter BR, Wang AZ, Bucca AW, Musey PI Jr, Strachan CC, Roumpf SK, Propst SL, Croft A, Menard LM, Kirschner JM. Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Sep 1;79(9):846-855. doi: 10.1001/jamaneurol.2022.1858.
- Background: PubMed 30845218Numata K, Shiga T, Omura K, Umibe A, Hiraoka E, Yamanaka S, Azuma H, Yamada Y, Kobayashi D. Comparison of acute vertigo diagnosis and treatment practices between otolaryngologists and non-otolaryngologists: A multicenter scenario-based survey. PLoS One. 2019 Mar 7;14(3):e0213196. doi: 10.1371/journal.pone.0213196. eCollection 2019.
- Derived from this study: PubMed 41196596Chi CY, Chen YC, Cheng MT, Chang KC, Chen YP, Tsai MS, Chang WT, Ma MH, Huang CH, Chiang WC. Diphenhydramine, Sodium Bicarbonate, or Combination for Acute Peripheral Vertigo: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2541472. doi: 10.1001/jamanetworkopen.2025.41472.
- Individual participant dataSharing planned: No
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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.
Chien-Yu Chi, MD principal investigator
Emergency Department, National Taiwan University, Yunlin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diphenhydramine, Sodium Bicarbonate and Diphenhydramine + Sodium Bicarbonate in people with Peripheral Vertigo, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Yu Chi, MD (+886 0972655833, Y06108@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in vertigo intensity (time frame: Baseline and 60 minutes after drug administration). 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 NCT05676216, 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 12 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.