Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

Korea Health Industry Development Institute

Status and phase

Terminated

Phase 2

Conditions

Chronic Subjective Dizziness

Treatments

Drug: Placebo tablet

Drug: JGT (Jaeumgeonbi-Tang) tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05482828

B100013

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)