Assessment of effectiveness, safety, and cost-effectiveness of an herbal medication (Gongjin-dan) for the patients with chronic dizziness

Not Applicable

• Conditions: Diseases of the nervous system

• Registration Number: KCT0002440
• Lead Sponsor: Kyung Hee University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1) Age between 20 and 79 years, of either sex
2) Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
3) Recurring symptom of dizziness for more than 1 month
4) Dizziness Handicap Inventory (DHI) score = 24 at baseline
5) Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
6) Willingness to provide written informed consent

Exclusion Criteria

1) Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)
2) Dizziness attributable to central nervous system (CNS) disorders (e.g., cerebellar ataxia, stroke, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines, and others)
3) Cervicogenic dizziness
4) Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others)
5) Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others)
6) Dizziness attributable to medication side effects
7) Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
8) Intake of other antivertiginous drugs that cannot be discontinued
9) Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness
10) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine > 3 × upper limit of normal range at baseline
11) Women of (suspected) pregnancy or breast-feeding
12) Allergic reactions to the study medications
13) Suspicion of alcohol and/or drug abuse
14 Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications
15) Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions
16) Other reason for ineligibility of participation

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI)

Secondary Outcome Measures

Name	Time	Method
Mean Vertigo Score (MVS);Visual Analogue Scale (VAS) ;Frequency of episodes (dizziness) ;Berg Balance Scale (BBS) ;Fatigue Severity Scale (FSS;Global Perceived Effect (GPE;Korean version of Beck Depression Inventory (K-BDI);State-Trait Anxiety Inventory (STAI) ;Qi Blood Yin Yang deficiency questionnaire (QBYY-Q) ;EuroQoL five dimensions questionnaire (EQ-5D;Medical expenses on dizziness;New Blinding index (New BI)