Efficacy and safety of Lycium chinense fruit extract (LFE) on improvement of liver functio
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003985
- Lead Sponsor
- Cheongyang-Gun Rich Farm Support Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT(Alanine transaminase);GGT(Gamma-glutamyltransferase)
- Secondary Outcome Measures
Name Time Method 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