Effects of Japanese apricot extract (Misatol GL) in patients with NAFLD /NASH

JRCT ID: jRCTs031180203

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: NAFLD/NASH
• Date of first enrollment: 23/02/2017
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Misatol GL or placebo twice (6.5g x 2) per day for 8 weeks

Outcome(s)

• Primary Outcome: Change in serum ALT
• Secondary Outcome: AST, ALT, GGT, ChoE, platelet, FiB-4 index

Key inclusion & exclusion criteria

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

Include criteria

1. Patients with hepatic steatosis is suspected by abdominal US, CT or MRI tests.
2. ALT higher than 60 IU/L
3. Patients who are able to provide written informed consent.

Exclude criteria

1. Patients who have serious liver disease (decompensated cirrhosis (Child-Pugh B<), liver cancer), whose ALT higher than 300 IU/L, or jaundice.
2. Other chronic liver disease (alcoholic liver disease, virus hepatitis, autoimmune hepatitis, metabolic liver disease)
3. Patients who have undergone bariatric surgery.
4. Pregnant woman, lactating woman, or a woman suspected of pregnancy.
5. Patients under insulin treatment.
6. Patients with severe cardiac disease.
7. Patients with severe kidney disease (CRE>2.0 mg/dL).
8. Patients who are unable to comply with administrative matters.
9. Patients who are allergic to the test foods.
10. Patients who have alcohol intake more than 30 g/day for male, and more than 20 g/day for female.
11. Patients who have participated in a clinical trials in the last 3 months.
12. Patients who are currently taking Misatol.
13. Patients who are judged by the investigator not to be appropriate for inclusion in the study.

Related Information

• Primary Sponsor: Zeniya Mikio
• Source(s) of Monetary Support: Otsuka Pharmaceutical Factory, Inc.
• Secondary ID(s): UMIN000025685