Clinical Study to Evaluate Effect on Fatty Liver and Safety of Trehalose

• Status: Completed
• Trial end date: 2018-03-20
• Target enrollment: 39
• Participant gender: All

Summary

This clinical study is conducted to evaluate the effect on fatty liver and safety of Trehalose, which is also called as mycose or tremalose, for participants with non-alcoholic fatty liver. After 12 weeks multiple-dose, participants will be checked up by CT scan to evaluate the effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

Criteria

Inclusion Criteria:

• Age between 19-year-old and 79-year-old

• Weight (≥50kg)

• Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day

• Has willingness and ability to participate whole clinical study period

• Willing to give informed consent form

Exclusion Criteria:

• Patient with alcoholic fatty liver

• Patient with inflammatory bowel disease

• Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study

• Has any medical history with virus or toxic hepatitis

• Has any medical history of gastrointestinal surgery (except simple appendectomy & repair of hernia)

• Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day

• Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator

• Over 4 times of maximum reference range of ALT or AST

• Average drinking quantity per week > alcohol 140 g

• Pregnant or nursing women

• Is currently participating into another clinical study

• Being made a decision from investigator as unsuitable to participate this study