Herbal Medication (Gongjin-dan) for Chronic Dizziness

Study Overview
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Brief Summary
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This is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial to explore the effectiveness of an herbal medication, Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis, the participants will be followed up to 12 months from randomization.

Official Title
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Safety, Effectiveness, and Cost-effectiveness of an Herbal Medicine, Gongjin-dan, in Subjects With Chronic Dizziness: a Prospective, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Clinical Trial

Conditions
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Dizziness Chronic

Intervention / Treatment
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* Drug: Gongjin-Dan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 79 years, of either sex Dizziness originating from Ménière disease, psychogenic cause, or unknown cause Recurring symptom of dizziness for more than 1 month Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors Willingness to provide written informed consent Exclusion Criteria: Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others) 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) Cervicogenic dizziness Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others) Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others) Dizziness attributable to medication side effects Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others) Intake of other antivertiginous drugs that cannot be discontinued Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), or creatinine > 3 × upper limit of normal range at baseline Women of (suspected) pregnancy or breast-feeding Allergic reactions to the study medications Suspicion of alcohol and/or drug abuse Enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications Difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions Other reason for ineligibility of participation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gongjin-dan<br>Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days). | Drug: Gongjin-Dan<br>* Gongjin-dan (Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea) is composed of Cervi Parvum, Angelica Gigas Root, Cornus Fruit, Ginseng, Steamed Rehmannia Root, and Musk.<br>|
| Placebo Comparator: placebo<br>Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days). | Drug: Placebo<br>* Placebo drugs (similar in appearance, taste, and odor to the Gongjin-dan) contains excipients, coloring agents, binders, flavoring agents, and preservative, and gilt-paper covering. Placebo pills of Gongjin-dan will be also made by Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI), change between baseline and endpoint | Assessment of the impairment caused by dizziness | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42 | Assessment of the impairment caused by dizziness | 14 days | 
| Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56 | Assessment of the intensity of dizziness | 28 days | 
| Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56 | Assessment of the intensity of dizziness | 28 days | 
| Frequency of episodes (dizziness), changes between baseline and day 28 and day 56 | The frequency score of dizziness | 28 days | 
| Berg Balance Scale (BBS), changes between baseline and day 28 and day 56 | Assessment of the balance impairment | 28 days | 
| Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56 | Assessment of the severity of chronic fatigue | 28 days | 
| Global Perceived Effect (GPE) | Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores | Day 56 | 
| Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56 | Assessment of the severity of depression | 28 days | 
| State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56 | Assessment of the severity of anxiety | 28 days | 
| Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56 | Assessment of the level of deficiency pattern/syndrome in traditional Korean medicine | 28 days | 
| EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment | Assessment of the level of quality of life | Day 0, Day 28, Day 56, Month 4, Month 8, Month 12 | 
| EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment | Assessment of the level of quality of life | Day 0, Day 28, Day 56, Month 4, Month 8, Month 12 |