Clinical trial NCT03219515: Herbal Medication (Gongjin-dan) for Chronic Dizziness
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dizziness Chronic
Lead sponsor: Kyunghee University
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI), change between baseline and endpoint
timeFrame: 56 days
Secondary outcomes:
measure: Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
timeFrame: 14 days
measure: Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Global Perceived Effect (GPE)
timeFrame: Day 56
measure: Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56
timeFrame: 28 days
measure: EuroQol five-dimensions questionnaire five-level (EQ-5D-5L), changes between baseline and each assessment
timeFrame: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
measure: EuroQol five dimensions questionnaire visual analogue scale (EQ VAS), change between baseline and each assessment
timeFrame: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
Other outcomes:
measure: Medical expenses on dizziness
timeFrame: Day 14, Day 28, Day 42, Day 56, Month 4, Month 8, Month 12
measure: New Blinding index (New BI)
timeFrame: Day 56
Locations:
city: Chungju
country: Korea, Republic of
facility: Semyung University Korean Medicine Hospital
state: Chungcheongbuk-do
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Oriental Hospital
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Korean Medicine Hospital
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
state: Special Seoul City
Study officials:
affiliation: Kyunghee University
name: Euiju Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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