Chronic Subjective DizzinessPhase 2NCT05482828
Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness
A Phase 2 study testing JGT (Jaeumgeonbi-Tang) tablet in people with Chronic Subjective Dizziness, run by Korea Health Industry Development Institute at 1 site in South Korea.
Trial summary
The goal of this study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Subjective Dizziness
- What is being tested?
- JGT (Jaeumgeonbi-Tang) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to 31 Dec 2013
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
[Inclusion Criteria]
- Chronic subjective dizziness patients, aged from 20 to 65
- DHI (Dizziness Handicap Inventory) score ≥ 24
- Those who can fully comprehend the general protocol of this study and voluntarily agree to participate
[Exclusion Criteria]
- Inner ear disease (benign paroxysmal positional vertigo, vestibular neuritis, Meniere's disease, etc.)
- Dizziness secondary to specific diseases such as hypoglycemia, recent stroke (within the last 6 months), or heart disease.
- Use of medications that could influence the result of the study (anticonvulsants, sedatives, antidepressants, sleeping pills, prostate medicine, Parkinson's drug, dementia drug, etc.)
- Pregnancy, breastfeeding, or plans of becoming pregnant
- Functional dyspepsia (persistent, recurring abdominal pain, or discomfort)
- Other allergic diseases
- Ineligibility for other reasons in the opinion of the research clinician (when the physician determines that there are significant physical or mental defects that the patient cannot understand and follow the protocol)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon Korean Medicine Hospital of Daejeon Unversity
Daejeon
About this study
Official title: Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial
The goal of this study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated.
Read the detailed description
This study's protocol was designed to assess the efficacy of JGT (Jaeumgeonbi-Tang) for chronic subjective dizziness.
- This design of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
- Symptoms and quality of life of chronic subjective dizziness patients will be evaluated.
- Dizziness severity and quality of life of the patients will be evaluated using DHI (Dizziness Handicap Inventory) (1) before treatment (baseline), (2) after 2 weeks, and (3) after 4 weeks of JGT treatment.
- Blood samples of the patients will be gathered before and after JGT treatment for pathophysiological analysis.
- Conditions
- Chronic Subjective Dizziness
- Being tested
- JGT (Jaeumgeonbi-Tang) tablet, Placebo tablet
- Keywords
- Chronic subjective dizziness, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JGT (Jaeumgeonbi-Tang) tabletDrug
Also called JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. Ltd
JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days
Placebo tabletDrug
Also called Corn starch tablet
Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days
| Study group | Role | What they receive |
|---|---|---|
| JGT group | Experimental | Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days Receives: Drug: JGT (Jaeumgeonbi-Tang) tablet |
| Placebo group | Placebo comparator | Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness handicap Inventory
The DHI (Dizziness Handicap Inventory) is a 25-item self-report questionnaire that quantifies the effect of dizziness on daily life by measuring the self-perceived handicap of the patients.
Measured: Change from Baseline DHI score at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startMay 2010
- Primary completionDec 2011
- Study completion31 Dec 2013
Why it stopped: The Sponser doesn't fund any more
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subjective DizzinessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, HoRyong Yoo, Korea Health Industry Development Institute
- Investigators
- Yoo HoRyong, KMD, PhD, Study director, Daejeon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482828
- Sponsor's protocol ID
- B100013
- Status last verified
- Oct 2023
- First submitted
- 22 Apr 2013
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05482828
- Acronym / sponsor ID
- B100013
- Conditions
- Chronic Subjective Dizziness
- Keywords
- Chronic subjective dizziness, Oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponser doesn't fund any more
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 1 Aug 2022 (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 study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated.
Detailed description
This study's protocol was designed to assess the efficacy of JGT (Jaeumgeonbi-Tang) for chronic subjective dizziness.
- This design of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
- Symptoms and quality of life of chronic subjective dizziness patients will be evaluated.
- Dizziness severity and quality of life of the patients will be evaluated using DHI (Dizziness Handicap Inventory) (1) before treatment (baseline), (2) after 2 weeks, and (3) after 4 weeks of JGT treatment.
- Blood samples of the patients will be gathered before and after JGT treatment for pathophysiological analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JGT group | Experimental | Drug: JGT (Jaeumgeonbi-Tang) tabletTreatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days |
| Placebo group | Placebo comparator | Drug: Placebo tabletPlacebo group: Corn starch tablet, 8 g t.i.d. for 28 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| JGT (Jaeumgeonbi-Tang) tabletAlso: JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. LtdJGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days | Drug | JGT group |
| Placebo tabletAlso: Corn starch tabletCorn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days | Drug | Placebo group |
Primary outcome
Dizziness handicap Inventory
Time frame: Change from Baseline DHI score at 4 weeks
The DHI (Dizziness Handicap Inventory) is a 25-item self-report questionnaire that quantifies the effect of dizziness on daily life by measuring the self-perceived handicap of the patients.
Results and safety
The study was stopped early (reason given: The Sponser doesn't fund any more). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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.
Yoo HoRyong, KMD, PhD study director
Daejeon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JGT (Jaeumgeonbi-Tang) tablet in people with Chronic Subjective Dizziness, run by Korea Health Industry Development Institute at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 10 Oct 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 South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The Sponser doesn't fund any more). Results are not available in the source record.
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 handicap Inventory (time frame: Change from Baseline DHI score at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.