Chronic Subjective Dizziness
Conditions
Keywords
Chronic subjective dizziness, Oxidative stress
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.
Interventions
DRUGJGT (Jaeumgeonbi-Tang) tablet
JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days
DRUGPlacebo tablet
Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dizziness handicap Inventory | 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. |
Countries
South Korea
Outcome results
None listed