Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

Chronic Subjective Dizziness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05482828
• Other study ID #: B100013
• Status: Terminated
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: December 31, 2013

Study information

• Verified date: October 2023
• Source: Korea Health Industry Development Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 31, 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

[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)

Related Conditions & MeSH terms

• Chronic Subjective Dizziness
• Dizziness
• Vertigo

Intervention

Drug:
• JGT (Jaeumgeonbi-Tang) tablet
JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days
• Placebo tablet
Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days

Locations

Country	Name	City	State
Korea, Republic of	Daejeon Korean Medicine Hospital of Daejeon Unversity	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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