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Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

Primary Purpose

Chronic Subjective Dizziness

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JGT (Jaeumgeonbi-Tang) tablet
Placebo tablet
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subjective Dizziness focused on measuring Chronic subjective dizziness, Oxidative stress

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

[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)

Sites / Locations

  • Daejeon Korean Medicine Hospital of Daejeon Unversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JGT group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
October 6, 2023
Sponsor
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05482828
Brief Title
Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness
Official Title
Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The Sponser doesn't fund any more
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Health Industry Development Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subjective Dizziness
Keywords
Chronic subjective dizziness, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JGT group
Arm Type
Experimental
Arm Description
Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days
Intervention Type
Drug
Intervention Name(s)
JGT (Jaeumgeonbi-Tang) tablet
Other Intervention Name(s)
JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. Ltd
Intervention Description
JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Other Intervention Name(s)
Corn starch tablet
Intervention Description
Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days
Primary Outcome Measure Information:
Title
Dizziness handicap Inventory
Description
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.
Time Frame
Change from Baseline DHI score at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoo HoRyong, KMD, PhD
Organizational Affiliation
Daejeon University
Official's Role
Study Director
Facility Information:
Facility Name
Daejeon Korean Medicine Hospital of Daejeon Unversity
City
Daejeon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

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