Clinical examination of Ninjinyoeito for frail in dialysis patients

Not Applicable

Recruiting

• Conditions: kidney failure, frailty; dialysis, frailty; D006435 D000073496

• Registration Number: JPRN-jRCTs021200021
• Lead Sponsor: OTA HIDETAKA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in SNAQ (Simplified Nutritional Appetite Questionnaire) score after 4,8,12 week of intervention

Secondary Outcome Measures

Name	Time	Method
Changes in the parameters described below after 4,8,12 week of intervention<br>: J-CHS criteria (body weight, grip strength, fatigue, walking speed, physical activity), MNA-SF(Mini Nutritional Assessment-Short Form), VI( Vitality Index), albumin level