Herbal Medication (Gongjin-dan) for Chronic Dizziness
- Registration Number
- NCT03219515
- Lead Sponsor
- Kyunghee University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days). Gongjin-dan Gongjin-Dan Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
- Primary Outcome Measures
Name Time Method Dizziness Handicap Inventory (DHI), change between baseline and endpoint 56 days Assessment of the impairment caused by dizziness
- Secondary Outcome Measures
Name Time Method Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42 14 days Assessment of the impairment caused by dizziness
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56 28 days The frequency score of dizziness
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56 28 days Assessment of the balance impairment
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56 28 days Assessment of the severity of anxiety
EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment Day 0, Day 28, Day 56, Month 4, Month 8, Month 12 Assessment of the level of quality of life
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56 28 days Assessment of the severity of chronic fatigue
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56 28 days Assessment of the intensity of dizziness
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56 28 days Assessment of the intensity of dizziness
Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56 28 days Assessment of the severity of depression
Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56 28 days Assessment of the level of deficiency pattern/syndrome in traditional Korean medicine
EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment Day 0, Day 28, Day 56, Month 4, Month 8, Month 12 Assessment of the level of quality of life
Global Perceived Effect (GPE) Day 56 Assessment of a patient's perception of symptom worsening or improvement, Patient-rated outcome, 1 item, 1-7 scores
Trial Locations
- Locations (4)
Semyung University Korean Medicine Hospital
🇰🇷Chungju, Chungcheongbuk-do, Korea, Republic of
Dongguk University Ilsan Oriental Hospital
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Pusan National University Korean Medicine Hospital
🇰🇷Yangsan, Gyeongsangnam-do, Korea, Republic of
Kyung Hee University Korean Medicine Hospital
🇰🇷Seoul, Special Seoul City, Korea, Republic of