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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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

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

Other trials in South Korea

About this study

Official title: Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial

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 groups in NCT05482828
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.

May 201031 Dec 2013

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)

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