Improvement of nonalcoholic fatty liver disease by pig placenta extract (PPE) supplementation-Pilot study-

JRCT ID: jRCTs041210149

Registered date:18/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonalcoholic fatty liver disease
• Date of first enrollment: 18/02/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Pig placenta extract (JBP porcine 100: 350mg/capsule),orally administered 6 Capsules/day for24 weeks

Outcome(s)

• Primary Outcome: AST (aspartate aminotransferase) and ALT (alanine transferase) before treatment and at 12, and 24 weeks of treatment
• Secondary Outcome: CLDQ, BMI, type IV collagen, hyaluronic acid, CT values, and liver stiffness before and at 24 weeks of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Nonalcoholic fatty liver disease
2) Consent is obtained in writing
3) BMI: 25kg/m2 or more
4) Drinking amount: less than 20g/day (600g/month)

Exclude criteria

1) Those who are allergic to pig placenta preparations
2) Pregnant or nursing mothers
3) Patients with severe liver disease (decompensated cirrhosis: Child-Pugh grade C, Hepatocellular carcinoma)
4) Those who cannot ingest pigs religiously
5) Patients judged by the principal investigator or sub-investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Mutsumi Tsuchishima