Clinical examination of Ninjinyoeito for frail in dialysis patients

JRCT ID: jRCTs021200021

Registered date:01/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: kidney failure, frailty
• Date of first enrollment: 04/09/2020
• Target sample size: 20
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Changes in SNAQ (Simplified Nutritional Appetite Questionnaire) score after 4,8,12 week of intervention

Secondary Outcome

Changes 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: OTA HIDETAKA
• Source(s) of Monetary Support: Kracie Pharma, Ltd.