Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

October 6, 2023 updated by: HoRyong Yoo, Korea Health Industry Development Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Daejeon Korean Medicine Hospital of Daejeon Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

[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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JGT group
Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days
Drug: JGT (Jaeumgeonbi-Tang) tablet
JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days
Other Names:
  • JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. Ltd
Placebo Comparator: Placebo group
Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days
Drug: Placebo tablet
Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days
Other Names:
  • Corn starch tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline DHI score at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Health Industry Development Institute

Investigators

  • Study Director: Yoo HoRyong, KMD, PhD, Daejeon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B100013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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