A human trial to evaluate the efficacy and safety of enzyme-treated Zizania latifolia (Griseb.) Turcz. ex Stapf extract powder on improvement of Liver function

A 8 weeks, multi-center, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of enzyme-treated Zizania latifolia (Griseb.) Turcz. ex Stapf extract powder on improvement of Liver function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005510

Enrollment

100

Registered

2020-10-20

Start date

2020-09-03

Completion date

Unknown

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : • enzyme-treated Zizania latifolia (Griseb.) Turcz. ex Stapf extract powder group: once a day, 2 tablets once, after breakfast, for 8 weeks(900 mg/day, 400 mg/day for enzyme-treat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Males and females aged over 19 years at the screening examination 2)Participants with 46 U/L=Alanine Transaminase(ALT), 65 U/L=Gamma-glutamyl transferase(GGT) 3)Participants who consume alcohol more than 14 unit/weeks for men and 7 unit/weeks for women 4)Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1) GGT, ALT or AST > 3-fold of normal range 2) Individual with cirrosis, liver cancer or sign of liver cancer 3) Taking the liver function improving supplements or medicine within previous 1 month 4) Participation in other clinical trials within the previous 3 months 5) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Design outcomes

Primary

Measure	Time frame
ALT(Alanine transaminase);GGT(Gamma-glutamyltransferase)	—

Secondary

Measure	Time frame
liver function index;Lipids Metabolism index;steatosis index;Antioxidant index;MFS(Multidimensional Fatigue Scale)	—

Countries

Korea, Republic of

Contacts

Public ContactJongcheon Joo

Wonkwang University Oriental Medical Hospital, Jeonju

Outcome results