Meniere's disease Meniere's disease
Conditions
Interventions
Arm: Test drug
Test drug: ethical Kampo formulation Ryokeijutsukanto extract fine granule (EK-39).
The study drug is administered a daily dosage of 6 g, three times a day, before, between, or after me
Sponsors
Kainuma Mosaburo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient who falls under all of the following category from 1) to 5). 1) Patient over 20 years old regardless of gender. 2) Patient who fall under any of the certain Meriere disease, definite Meriere disease, or probable Meriere disease in the diagnostic criteria for Meniere disease of the Clinical Practice Guidelines for Meniere Disease and Delayed Endolymphatic Hydrops 2020, Japan Society for Equilibrium Research. 3) Patient who have been taking isosorbide continuously for the last 4 weeks at the time of entry. 4) Patient who have had vertigo attacks every month for the last 3 months at the time of entry. 5) Patient who has consented to this clinical trial.
Exclusion criteria
Exclusion criteria: Patient who falls under any of the following category from 1) to 5). 1) Patient with unstable general condition or any comorbidity that may affect the results of the clinical trial. 2) Patient who has any factor that make it difficult to take the study drug or control drug continuously. (e.g. dysphagia) 3) Patient with aldosteronism, myopathy, or hypokalemia. 4) Patient with lactose intolerant. (patient who develop watery diarrhea, abdominal distension, excessive flatulence, nausea, borborygmus, abdominal cramps, etc. after ingestion of dairy products.) 5) Patient who is considered inappropriate to enroll in the clinical trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of vertigo attacks | — |
Secondary
| Measure | Time frame |
|---|---|
| Vertigo level, subjective distress level, activity level, adverse event | — |
Contacts
Public ContactHiromasa Takakura
Toyama University Hospital
Outcome results
None listed