KCT0002440
Not yet recruiting
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University
- Enrollment
- 78
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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