DBT of Ninjin'yoeito for NAFLD

Study of Ninjin' yoeito effect on NAFLD patients with fatigue and weakness, a double blind randomized controlled trial (NYT for NAFLD) - DBT of Ninjin' yoeito for NAFLD (NYT for NAFLD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071200113

Enrollment

Registered

2021-03-11

Start date

2021-07-21

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

Nonalcoholic fatty liver disease

Interventions

Oral administration of placebo/ninjin'yoeito (7.5g) twice a day before or between meals

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) NAFLD patients with liver fibrosis (Stage 2 or higher) estimated by Fibro Scan : M probe > 7.8 kPa, XL probe > 6.4 kPa 2) Outpatients aged 45 years and older who are at risk of developing NAFLD / NASH 3) Patients with FA (fatigue) items of 5 or less by The CLDQ-NASH Instrument 4) Patients who can understand the contents of informed consent form and can voluntarily sign the form

Exclusion criteria

Exclusion criteria: 1) Patients with cirrhosis 2) Patients with the following conditions for cirrhosis a. Platelet count 150,000 /uL or less b. Patients with varicose veins, jaundice, ascites 3) Patients taking the following drugs a. Oral steroids b. Antineoplastic drugs 4) Patients who onset malignant tumor within 5 years before the start of the study 5) Patients suspected of pseudoaldosteronism (Serum potassium 3.5 mEq/L or less) 6) Patients with history of allergic response/pseudoaldosteronism to ninjin'yoeito 7) Patients who the investigator determined difficult to participate in the study

Design outcomes

Primary

Measure	Time frame
Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after interventions for 48 weeks	—

Secondary

Measure	Time frame
In addition to the overall study, the following items (1) through (5) will be analyzed by stratification (sarcopenia group / non-sarcopenia group) according to the background factors (presence of sarcopenia comorbidity) at the start of this study. 1) Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after 12,24,36,48 week of intervention 2) Changes in the parameters described below after 12,24,36,48 week of intervention : body weight, grip strength, SMI, Kihon Check List for Frailty, blood test (liver function, insulin, sugar metabolism, blood count, renal function, electrolyte) 3) Changes in the parameters described below after 48 week of intervention. : Computed Tomography (Skeletal muscle mass, skeletal muscle mass (lean fat), intramuscular fat mass, body fat mass, CT-SMI) 4) Changes in the parameters described below after 24,48 week of intervention : blood test (fibrosis, inflammation), imaging analysis, ultrasonography 5) Changes between the end of the study drug administration and 3 weeks after the study drug administration : 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) 6) Active group: Correlation analysis between the changes of QOL score and other parameters at baseline or changes in those 7) Active group: Comparison between the subjects with improvement in QOL and ones without improvement in QOL. 8) Changes in sarcopenia comorbidity after 24,48 week of intervention. 9) Changes in the proportion of the subjects with impaired QOL according to the QOL score after 24,48 week of intervention.	—

Measure

Time frame

In addition to the overall study, the following items (1) through (5) will be analyzed by stratification (sarcopenia group / non-sarcopenia group) according to the background factors (presence of sarcopenia comorbidity) at the start of this study. 1) Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after 12,24,36,48 week of intervention 2) Changes in the parameters described below after 12,24,36,48 week of intervention : body weight, grip strength, SMI, Kihon Check List for Frailty, blood test (liver function, insulin, sugar metabolism, blood count, renal function, electrolyte) 3) Changes in the parameters described below after 48 week of intervention. : Computed Tomography (Skeletal muscle mass, skeletal muscle mass (lean fat), intramuscular fat mass, body fat mass, CT-SMI) 4) Changes in the parameters described below after 24,48 week of intervention : blood test (fibrosis, inflammation), imaging analysis, ultrasonography 5) Changes between the end of the study drug administration and 3 weeks after the study drug administration : 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) 6) Active group: Correlation analysis between the changes of QOL score and other parameters at baseline or changes in those 7) Active group: Comparison between the subjects with improvement in QOL and ones without improvement in QOL. 8) Changes in sarcopenia comorbidity after 24,48 week of intervention. 9) Changes in the proportion of the subjects with impaired QOL according to the QOL score after 24,48 week of intervention.

—

Contacts

Public ContactHirokazu Takahashi

Saga University Hospital

takahas2@cc.saga-u.ac.jp+81-952-34-2362

Outcome results

None listed

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