Study of Ryokeijutsukanto for Meniere's disease

JRCT ID: jRCTs041200115

Registered date:29/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Meniere's disease
• Date of first enrollment: 02/12/2021
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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 meals for 4 weeks. In practice, a single dosage of 2 g of extract fine granules is placed in 6 opaque capsules, and 6 capsules are administered three times a day (6g/day, 18 capsules/day). Depending on the age, weight, etc., it is possible to take at least 4 g (12 capsules) daily.
Arm: Control drug
Control drug: Japanese Pharmacopoeia, lactose hydrate (powder).
The control drug is administered a daily dosage of 6 g, three times daily, before, between, or after meals for 4 weeks. In practice, a single dosage of 2 g of lactose is placed in 6 opaque capsules and 6 capsules are administered three times a day (6g/day, 18 capsules/day). Depending on the age, weight, etc., it is possible to take at least 4 g (12 capsules) daily.

Outcome(s)

• Primary Outcome: Number of vertigo attacks
• Secondary Outcome: Vertigo level, subjective distress level, activity level, adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shojaku Hideo
• Secondary Sponsor: Shimada Yutaka