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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
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.
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.
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, South Korea
Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnam-do, South Korea
Semyung University Korean Medicine Hospital
Chungju, North Chungcheong, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, Special Seoul City, South Korea
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
Assessment of the impairment caused by dizziness
Time frame: 56 days
Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42
Assessment of the impairment caused by dizziness
Time frame: 14 days
Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Time frame: 28 days
Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56
Assessment of the intensity of dizziness
Time frame: 28 days
Frequency of episodes (dizziness), changes between baseline and day 28 and day 56
The frequency score of dizziness
Time frame: 28 days
Berg Balance Scale (BBS), changes between baseline and day 28 and day 56
Assessment of the balance impairment
Time frame: 28 days
Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56
Assessment of the severity of chronic fatigue
Time frame: 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
Time frame: 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
Time frame: 28 days
State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56
Assessment of the severity of anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0, Day 28, Day 56, Month 4, Month 8, Month 12
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