DBT of Ninjin'yoeito for NAFLD

JRCT ID: jRCTs071200113

Registered date:11/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonalcoholic fatty liver disease
• Date of first enrollment: 21/07/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Oral administration of placebo/ninjin'yoeito (7.5g) twice a day before or between meals

Outcome(s)

• Primary Outcome: Changes in QOL score (The CLDQ-NASH Instrument, Fatigue impact scale ) after interventions for 48 weeks

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Anzai Keizo
• Source(s) of Monetary Support: Kracie Pharmaceutical, Ltd.