A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of NVP-1702 on improving liver function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002927

Enrollment

Registered

2018-06-15

Start date

2017-12-07

Completion date

Unknown

Last updated

2023-03-06

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 : individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study Intervention: once a day, 2 capsules for 12 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female subject aged between 19 years and 75 years 2) Subjects with AST(Aspartate Aminotransferase)(GOT) level 45~120U/L or ALT(Alanine Aminotransferase)(GPT) level 45~120U/L 3) Subjects with a body mass index (BMI) of 23 kg / m^2 or more 4) Subjects who agree to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Subject with liver cirrhosis or hepatoma on ultrasonography 2) Subject with ?-GTP(Gamma Glutamyl Transpeptidase) > 210U/L 3) During the past one month in the drinking lifestyle survey, more than the average male in a week 14-unit, female in a week 7-unit 4) Subject with Alkaline Phosphatase(ALP) = 390U/L or Platelet = 10^5/ul or AFP(a-fetoprotein) > 20 ng/mL 5) Subject diagnosed with viral hepatitis 6) Subject with HBs Ag(Hepatitis C Virus Antibodies) or HCV Ab(Hepatitis C Virus Antibodies) positive in screening test 7) Subject with Albumin = 3.5g/dl or Total Bilirubin = 3 mg/dl 8) Subject with Creatinine = 2.4mg/dL 9) Subject who TSH(Thyroid Stimulating Hormone) = 0.1uU/ml and = 10uU/ml 10) Subject who taking a drug influence of liver function (INH(isoniazid), valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac, the potential to cause liver toxicy.)within 4 weeks 11) Subject taking cholagogues, cholelitholytics, hepatic Protectors, antidotes, detoxifying agents and drugs used in substance dependence within 4 weeks 12) Subject taking the asian herb, Vit(vitamin). E supplement, Liver function improvement and related health supplements within 2 weeks 13) Subject taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks 14) Subjects who cannot take a Investigational Product because of heartburn, indigestion and severe gastrointestinal symptoms 15) Pregnant or get the pregnant person during a clinical trial 16) planning to participate in other clinical trial during the clinical trial 17) Who was participated in the clinical trials to the start of the study within a month 18) Investigator this clinical trial the person who are deemed inappropriate

Design outcomes

Primary

Measure	Time frame
AST, ALT	—

Secondary

Measure	Time frame
Multidimensional Fatigue Scale(MFS);vital sign	—

Countries

Korea, Republic of

Contacts

Public ContactHee Chul Kang

Yonsei University Health System, Severance Hospital

kanghc@yuhs.ac+82-2-2228-2332

Outcome results