NIPH Clinical Trials Search

JRCT ID: jRCTs021200021

Registered date:01/09/2020

Clinical examination of Ninjinyoeito for frail in dialysis patients

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedkidney failure, frailty
Date of first enrollment04/09/2020
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)3.75 g of Ninjinyoeito extract fine granules is orally administered twice a day before or between meals. -The start date of administration should be within 4 weeks from the date of registration. If administration is not possible after more than 4 weeks, re-qualification is performed. -Study drug is administered daily for 12 weeks.


Primary OutcomeChanges in SNAQ (Simplified Nutritional Appetite Questionnaire) score after 4,8,12 week of intervention
Secondary OutcomeChanges in the parameters described below after 4,8,12 week of intervention : J-CHS criteria (body weight, grip strength, fatigue, walking speed, physical activity), MNA-SF(Mini Nutritional Assessment-Short Form), VI( Vitality Index), albumin level

Key inclusion & exclusion criteria

Age minimum>= 65age old
Age maximumNot applicable
Include criteria1) Dialysis patients 2) Patients who are diagnosed as frail or pre-frail based on J-CHS criteria 3) Patients 65 years or older at the time of consent acquisition 4) Patients with SNAQ score of 14 or less 5) Patients who can understand the contents of informed consent form and can voluntarily sign the form
Exclude criteria1) Patients who have taken Kampo medicines within one month before the start of the study 2) Patients who started or changed the administration of psychotropic drugs, nootropics, antidepressants, mood stabilizers, psychostimulants, anxiolytics, or sleeping pills within 3 months before the start of the study 3) Patients with malignant tumor 4) Patients who have difficulty walking independently 5) Patients who the investigator determined difficult to participate in the study

Related Information


Public contact
Address 1-1-1, Hondo, Akita-city, Akita Akita Japan 010-8543
Telephone +81-18-884-6085
Affiliation Akita University
Scientific contact
Address 1-1-1, Hondo, Akita-city, Akita Akita Japan 010-8543
Telephone +81-18-884-6085
Affiliation Akita University