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Study of Ninjinyoeito for frail in dialysis patients

Clinical examination of Ninjinyoeito for frail in dialysis patients : a single-group, open-label, multicenter study - Study of Ninjinyoeito for frail in dialysis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021200021
Enrollment
13
Registered
2020-09-01
Start date
2020-09-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney failure

Interventions

A daily dose 7.5 g of Ninjinyoeito extract fine granules is orally administered twice a day before or between meals

Sponsors

OTA HIDETAKA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Dialysis patients 2) Patients who are diagnosed as frail or pre-frail based on revised 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

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

Design outcomes

Primary

MeasureTime frame
Changes in SNAQ (Simplified Nutritional Appetite Questionnaire) score after 4,8,12 week of intervention

Secondary

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

Contacts

Public ContactOTA HIDETAKA

Akita University

hidetaka-ota@med.akita-u.ac.jp+81-18-884-6085

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026