Efficacy and safety of Lycium chinense fruit extract (LFE) on improvement of liver function

A 12 week, randomized, double blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Lycium chinense fruit extract (LFE) on improving liver function in subject with impaired hepatic function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003985

Enrollment

Registered

2019-05-24

Start date

2018-06-27

Completion date

Unknown

Last updated

2020-03-23

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 : A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Lycium chinense fruit extract (LFE) on improving liver func

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 19 ~ 70 years of age 2) ALT level 35~105 IU/L 3) Subjects who agree to participated in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) AST or GGT > 3-fold of normal range 2) Subjects who usually drink alcohol as follows within 3 months - Male > 210 g/weeks - Female > 140 g/weeks 3) Patients with acute or chronic hepatitis or carriers of viral hepatitis (type B or C) 4) History of underlying cirrhosis and liver cancer 5) History of underlying biliary diseases such as jaundice or gallstones (But, asymptomatic gallstones etc. can be enrolled under the judgment of the researcher) 6) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc. 7) Administration of drugs that affect liver function (antiviral drugs, antituberculosis drugs, antiseizure drugs, arthrifuge, antidepressant, lipid-lowering agents, anesthetic agents, hepatoprotective agents, NSAIDs etc.), adrenal cortex hormones or sex hormone within 4 weeks 8) Taking the liver function improving supplements (Milk thistle etc.), oriental medicine, OTC(Over The Counter) within 2 weeks 9) Allergic or hypersensitivity to drug and any of the ingredients in the test products (Lycium chinense, crystalline cellulose etc.) 10) History of substance abuse 11) History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery 12) Participation in other clinical trials within the previous two months 13) Pregnant, planning to become pregnant, or breast-feeding 14) emale subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility) 15) Laboratory test by show the following results ? Serum creatinine > 2.0 mg/dL 16) 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
AST (Aspartate Transaminase);ALP (Alkalin Phosphatase);Controlled Attenuation Parameter;Total cholesterol;Triglyceride;High Density Lipoprotein Cholesterol;Low Density Lipoprotein Cholesterol;Total Antioxidant Capacity;High Sensitivity C-Reactive Protein(hs-CRP);Multidimensional Fatigue Scale	—

Countries

Korea, Republic of

Contacts

Public ContactMi-Ra Oh

Chonbuk National University Hospital

Outcome results