Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Subjective Dizziness

Intervention / Treatment
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* Drug: JGT (Jaeumgeonbi-Tang) tablet
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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[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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic subjective dizziness, Oxidative stress