Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

Phase 2

Terminated

• Conditions: Chronic Subjective Dizziness
• Interventions: Drug: JGT (Jaeumgeonbi-Tang) tablet; Drug: Placebo tablet

• Registration Number: NCT05482828
• Lead Sponsor: Korea Health Industry Development Institute

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-12
• Study First Submitted: 2013-04-22
• Study Completion: 2013-12-31
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JGT group	JGT (Jaeumgeonbi-Tang) tablet	Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days
Placebo group	Placebo tablet	Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Daejeon Korean Medicine Hospital of Daejeon Unversity; 🇰🇷 Daejeon, Korea, Republic of