Clinical Trial Details

Trial ID: L0391
Source ID: JPRN-jRCTs071200113
Associated Drug: Ninjin'yoeito
Title: Study of Ninjin'yoeito effect on NAFLD patients with fatigue and weakness, a double blind randomized controlled trial - NYT for NAFLD
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic fatty liver disease
Interventions: Oral administration of placebo/ninjin'yoeito (7.5g) twice a day before or between meals
Outcome Measures: Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after interventions for 48 weeks1) Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after 12,24,36,48 week of intervention<br>2) Changes in the parameters described below after 12,24,36,48 week of intervention<br>: body weight, grip strength, SMI, Kihon Check List for Frailty, blood test (liver function, insulin, sugar metabolism, blood count, renal function, electrolyte)<br>3) Changes in the parameters described below after 48 week of intervention.<br>: Computed Tomography (Skeletal muscle mass, skeletal muscle mass (lean fat), intramuscular fat mass, body fat mass)<br>4) Changes in the parameters described below after 24,48 week of intervention<br>: blood test (fibrosis, inflammation), imaging analysis, ultrasonography<br>5) Changes between the end of the study drug administration and 3 weeks after the study drug administration<br>: body weight, grip strength, SMI, QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ), Kihon Check List for Frailty, blood test (liver function, insulin, sugar metabolism, blood count, renal function, electrolyte)<br>6) Active group: Correlation analysis between the changes of QOL score and other parameters at baseline or changes in those<br>7) Active group: Comparison between the subjects with improvement in QOL and ones without improvement in QOL.
Sponsor/Collaborators: Anzai Keizo
Gender: All
Age: >= 45age oldNot applicable
Phases: Not applicable
Enrollment: 60
Study Type: Interventional
Study Designs: randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
Start Date: 11/03/2021
Completion Date: --
Results First Posted: --
Last Update Posted: 10 January 2022
Locations: Japan
URL: https://jrct.niph.go.jp/latest-detail/jRCTs071200113