clinical trial for the evaluation of the efficacy and safety of IBT-Pr on improving liver function

A 12 week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of IBT-Pr on improving liver function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003871

Enrollment

Registered

2019-04-30

Start date

2019-01-16

Completion date

Unknown

Last updated

2019-05-20

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 : The participants enrolled in this study was assigned to 2 groups by double-blinde randomization. IBT-Pr group: Take IBT-Pr with water, 2cap/1time, 1time/1day, 12weeks placebo gr

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) level 45-135U/L or ALT(GPT) level 40-120U/L

Exclusion criteria

Exclusion criteria: 1) Subject who are taking treatment(hospitalization, medication, rehabilitation) due to alcohol abuse, alcohol-related disease, heart disease and central nervous disorder 2) Subject with liver cirrhosis or hepatoma on ultrasonography 3) During the past one month in the drinking habit survey, more than the average male in a week 14unit, female in a week 7unit 4) Subjects with ?-GTP(Gamma Glutamyl Transpeptidase) = the upper limit of normal levels(ULN)?4 5) ALP = the upper limit of normal levels(ULN)?3 or Platelet = Platelet 105/µL or AFP > 20ng/mL 6) Subject who currently diagnosed with viral hepatitis 7) Subject who has positive with HBs Ag or HCV Ab in screening 8) Albumin = 3.5g/dl or Total Bilirubin = 3mg/dl 9) Subject who took a medication that affects the liver funtion, Cholagogues, Cholelitholytics, Hepatic Protectors, Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence, adrenal cortical hormone or sex hormone within 4 weeks 10) Subject who took an antiviral agent, antibiotics, oriental medicine, vitamine E supplement or health functional food related with liver function improvement within 2weeks

Design outcomes

Primary

Measure	Time frame
AST(Aspartate Transaminase), ALT(Alanine Transaminase), ?-GTP(Gamma Glutamyl Transpeptidase);AST/ALT ratio;Multidimensional fatigue scale;Blood lipids(total cholesterol, Triglyceride, High density lipoprotein cholesterol, Low density lipoprotein cholesterol)	—

Secondary

Measure	Time frame
Adverse event, clinical lab, vital sign, body weight	—

Countries

Korea, Republic of

Contacts

Public ContactSEUNGHYUN KANG

H Plus Yangji Hospital

juspa@naver.com+82-70-4665-9490

Outcome results