None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to a treatment or control group. The treatment group will receive 400 mg of Citrus aurantium extract as a tablet twice daily 30 minutes after me
Sponsors
NutraPharmTech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subject aged between 20 years and 75 years 2) Subject with abnormal serum AST(GOT) or ALT(GPT) level and less than 3 times the upper limit of normal. 3) Subject who agrees to participate in the study and signs the informed consent form
Exclusion criteria
Exclusion criteria: 1) Subject with a history of hospitalization, a medication or rehabilitation therapy to treat alcohol use disorders, alcohol-induced disorders, cardiac disorders and central nervous system diseases 2) Subject with cholelithiasis or gallstone 3) Subject with liver cirrhosis or hepatoma on ultrasonography 4) Subject with Alkaline Phosphatase(ALP) = 3 times the upper limit of normal or Platelet 20 ng/mL 5) Subject diagnosed with viral hepatitis 6) Subject with HBs Ag or HCV Ab positive in screening test 7) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl 8) Subject with Creatinine = 2 times the upper limit of normal 9) Subject taking a drug influence of liver function (INH, valproic acid,tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac etc, the potential to cause liver toxicy) within 4 weeks 10) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks 11) Subject taking any Chinese herbs or health functional foods related to liver function within 2 weeks 12) Subject taking an adrenal cortical hormone or sex hormone within 4 weeks 13) Subject with uncontrolled hypertension (over 160/100mmHg, when measuring after 10 minutes steady) 14) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose or start taking other diabetes medications within 3 months) 15) Subject taking a new antihyperlipidemic drug within 3 months. (If a subject is taking an antihyperlipidemic drug before 3 months, the subject can participate in this study.) 16) Subject with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia 17) Subject who is pregnant or planning to pregnant within 3 months 18) Subject planning to participate in the other clinical study 19) Subject participated in any clinical trial within 1 month 20) Inappropriate subject decided by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum Aspartate Aminotransferase(AST) level | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of serum Alanine transaminase(ALT) and Gamma-glutamyl transpeptidase(r-GTP) levels;Change of AST/ALT ratio;Change of Multidimensional Fatigue Scale (MFS) ;Change of blood lipid profile(Total-cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol) ;Measurement of liver fat using CT scan: liver attenuation HU(Hounsfield Unit) and spleen attenuation HU, difference between liver HU and spleen HU, ratio of liver HU to spleen HU;Change of antioxidative markers (Malondialdehyde(MDA), Total Antioxidant Status(TAS)) | — |
Countries
Korea, Republic of
Contacts
Public ContactKYUNG SOO KIM
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed