Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

NCT ID: NCT05482828

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Subjective Dizziness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JGT group

Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days

Group Type EXPERIMENTAL

JGT (Jaeumgeonbi-Tang) tablet

Intervention Type DRUG

JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days

Placebo group

Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JGT (Jaeumgeonbi-Tang) tablet

JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days

Intervention Type DRUG

Placebo tablet

Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. Ltd Corn starch tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

HoRyong Yoo

Associate Professor, Daejeon University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yoo HoRyong, KMD, PhD

Role: STUDY_DIRECTOR

Daejeon University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Daejeon Korean Medicine Hospital of Daejeon Unversity

Daejeon, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B100013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.