None listed
Conditions
Interventions
Dietary Supplement : Subjects is randomly allocated to either experimental or placebo group and take test material(freeze-dried matured silkworm 1.5g/day) or placebo twice a day, each time 3 capsules
Sponsors
ChongKunDang Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female between 19-75 years 2) ?-GTP = 70 IU/L and = 180 IU/L 3) In the alcohol drinking style survey, Subject who drinks more than average 14 unit of male, 7 unit of female per week during the past month. 4) Subject who voluntarily agrees to participate and sign in informed consent form
Exclusion criteria
Exclusion criteria: 1) Subject who are admitted to hospital, medication or rehabilitation due to alcohol use disorder ? related disorder, heart disease, central nervous disorder, etc 2) Abdominal ultrasound exam showed liver cirrhosis or liver cancer patients 3) Subject who more than 3times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution 4) Subject who more than 3times the upper limit of normal ALP or Platelet = 105/µL or AFP > 10ng/mL 5) Subject who have been diagnosed with viral hepatitis 6) Subjcet who were positive HBs Ag or HCV Ab in screening test 7) Subject who Albumin = 3g/dl or Total Bilirubin = 3mg/dl 8) Subject who more than 1.5times the upper limit of normal Creatinine 9) Uncontrolled thyroid disease patient 10) Subject who was taking drugs the affects liver function within 4 weeks of study(antituberculosis drugs, anticonvulsants, arthrifuges, antidepressants and other drugs that may cause hepatotoxicity) 11) Subject who was taking NSAIDs, antiviral agents, antibiotics within 2 weeks of study 12) Subject who was taking cholagogues, Cholelitholytics & Hepatic Protectors, antidotes, Detoxifying Agents & Drugs Used in Substance Dependence within 4 weeks of study 13) Subject who was taking herbal medicine, Vitamine.E supplements, and health functional foods related to liver function improvement within 2 weeks of study 14) Subject who was taking corticosteroids or sex hormones within 4 weeks of study 15) Patients with uncontrolled hypertension(systolic BP = 160 mmHg or diastolic BP = 100 mmHg, measurement after stabilization for 10 minutes of test subjects 16) Uncontrolled diabetic(fasting blood glucose = 180mg/dl or If the drug is newly started or changed due to diabetes within 3 months or in case of using of insulin) 17) Subject who have dosed Anti-phospholipid drugs within 3 months (They can participate if they have been on treatment since 3 months) 18) Subject who have severe gastrointestinal symptoms such as heartburn, indigestion, etc. 19) Subject who is pregnant or has a pregnancy plan during the period of the clinical trial 20) Subject who has planned to participate in other clinical trials during the clinical trial study 21) Subject who have participated other clinical trials within the past month 22) Subject who the opinion investigator make a judgment to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of ?-GTP | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of AST, ALT;Change of AST/ALT ratio;Multidimensional Farigue Scale(MFS);Total Cholesterol, Triglyceride, HDL-Cholesterol, LDL-Cholesterol;treatment-emergent adverse events(TEAEs);clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony);Weight;electrocardiography | — |
Countries
Korea, Republic of
Contacts
Public ContactDoori Choi
Bundang Jesaeng Hospital
Outcome results
None listed