Clinical trial: Herbal Medication (Gongjin-dan) for Chronic Dizziness (NCT03219515)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment