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临床试验/KCT0002440
KCT0002440尚未招募未知

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

Kyung Hee University0 个研究点目标入组 78 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
入组人数
78

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 79(Year)(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

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