NCT03219515Unknown不适用
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
Kyunghee University4 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Dizziness Handicap Inventory (DHI), change between baseline and endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Gongjin-dan
Experimental
Participants will be orally administered Gongjin-dan pills of 3.75g, 1 pill/day, 8 weeks (56 days).
干预措施: Gongjin-Dan (Drug)
placebo
Placebo Comparator
Participants will be orally administered placebo pills of 3.75g, 1 pill/day, 8 weeks (56 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Dizziness Handicap Inventory (DHI), change between baseline and endpoint
时间窗: 56 days
Assessment of the impairment caused by dizziness
次要结局
- Dizziness Handicap Inventory (DHI), change between baseline and day 14, day 28, day 42(14 days)
- Frequency of episodes (dizziness), changes between baseline and day 28 and day 56(28 days)
- Berg Balance Scale (BBS), changes between baseline and day 28 and day 56(28 days)
- State-Trait Anxiety Inventory (STAI), changes between baseline and day 28 and day 56(28 days)
- 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)
- Fatigue Severity Scale (FSS), changes between baseline and day 28 and day 56(28 days)
- Mean Vertigo Score (MVS), changes between baseline and day 28 and day 56(28 days)
- Visual Analogue Scale (VAS), changes between baseline and day 28 and day 56(28 days)
- Korean version of Beck Depression Inventory (K-BDI), changes between baseline and day 28 and day 56(28 days)
- Qi Blood Yin Yang deficiency questionnaire (QBYY-Q), changes between baseline and day 28 and day 56(28 days)
- 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)
- Global Perceived Effect (GPE)(Day 56)
研究者
Lee Eui-ju
Professor, Ph.D. KMD.
Kyunghee University
研究点 (4)
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