Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness

NCT05482828 | Terminated Phase 2 DMC

• 1 other identifier: B100013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subjective Dizziness

Keywords

Chronic subjective dizziness; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

JGT group

EXPERIMENTAL

Treatment group: JGT (Jaeumgeonbi-Tang) tablet. 8 g t.i.d. for 28 days

Drug: JGT (Jaeumgeonbi-Tang) tablet

Placebo group

PLACEBO COMPARATOR

Placebo group: Corn starch tablet, 8 g t.i.d. for 28 days

Drug: Placebo tablet

Interventions

JGT (Jaeumgeonbi-Tang) tablet DRUG

JGT tablet (composed of 19 herbs), 24 g daily (single dose=8 g), t.i.d. for 28 days

Also known as: JGT (Jaeumgeonbi-Tang) tablet, Hanpoong Co. Ltd

JGT group

Placebo tablet DRUG

Corn starch tablet, 24 g daily (single dose=8 g), t.i.d. for 28 days

Also known as: Corn starch tablet

Placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Korea Health Industry Development Institute: lead

Study Sites (1)

Daejeon Korean Medicine Hospital of Daejeon Unversity

Daejeon, South Korea

Location

MeSH Terms

Interventions

Tablets; Starch

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Yoo HoRyong, KMD, PhD

  Daejeon University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Daejeon University

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: August 1, 2022
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 31, 2013
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)