A 12-week, Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KBL982 on Improving Alcoholic Liver Dysfunctio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006987
- Lead Sponsor
- Kobiolabs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 105
1) Males and females aged over 19 years, under 75 years at the screening examination
2) Participants who exceeds the upper limit and is within three times the upper limit
3) Participants who consume alcohol more than 20g/day for men and 10g/day for women
4) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions
1) Those who are hospitalized, mediated, and rehabilitated due to heart disease and central neurological disorders.
2) Those who have severe alcohol use disorders based on DSM-V.
3) Patients with cirrhosis or liver cancer according to abdominal ultrasonography based on visit 2
4) Those who have received chemotherapy or are being treated for malignant tumors other than basal cell carcinoma and squamous cell carcinoma (restrained non-invasive lesions) or those who have been cured of cancer for less than 5 years.
5) Those whose AST (GOT) or ALT (GPT) is 5 times or more of the normal upper limit of the implementation engine.
6) A person whose ALP is three times or more than the normal upper limit of the implementation engine, whose platelet is 105/µL or less, or whose AFP is more than 10 ng/mL.
7) In Visit 1, a positive factor for HBs Ag or HCV Ab test.
8) less than 3 g/dL of albumin or greater than 3 mg/dL of total bilirubin.
9) Those whose creatine is 1.5 times or more than the upper limit of normal range
10) Uncontrolled thyroid disease patients.
11) Those who took drugs that affect liver function within 4 weeks of visit 1 (anti-tuberculosis, anticonvulsant, gout therapy, antidepressant, and other drugs that may cause hepatotoxicity).
12) Within 4 weeks of visit 1, Those who took Biphenyl Dimethyl Dicarboxylate, Cholagues, cholelitholytics, Antidotes, Detoxifying Agents & Drugs Used in Substance Defense.
13) Those who took NSAIDs, antiviral drugs, and antibiotics within 2 weeks of visit 1.
14) A person who took herbal medicine, Vit.E supplementation (800 IU or more), or health functional foods related to liver function improvement within 2 weeks of visit 1.
15) Those who have consumed probiotics health functional foods and foods containing lactobacillus continuously (more than four times a week) within two weeks of visiting 1.
16) Those who took adrenocortical hormones, sex hormones, or those who underwent hormone replacement therapy (HRT) within 4 weeks of visit 1.
17) Uncontrolled hypertensive patients (measurement criteria after stabilization of 10 minutes of subjects subject to human application test with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher)
18) Uncontrolled diabetic patients (if they start a new drug or have a dose change due to diabetes within 3 months or 180 mg/dL of fasting blood sugar, or if they receive insulin).
19) A person who received a new antiphospholipid-based drug within 3 months of visit 1 (if administered without a change in dose from 3 months ago, he/she can participate)
20) A person who has been newly administered with a vitamin B complex drug (UDCA: Ursodocy Cholic Acid, Silymarin, etc.) within 3 months of visit 1 (if administered without any change in dose from 3 months ago, he/she can participate)
21) A person who complains of severe gastrointestinal symptoms such as heartburn and indigestion and has a problem in eating food for human application tests.
22) Those who are sensitive or allergic to food ingredients for this human application test.
23) A person who is pregnant or has plans to become pregnant during the human body application test.
24) Those who participated in other interventional clinical trials (including human application trials) within 1 month of visit 1, or who plan to participate in other interventional clinical trials (including human application trials) after the start of this human application trial.
25) A p
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gamma-Glutamyl Transferase
- Secondary Outcome Measures
Name Time Method Aspartate Aminotransferase, Alanine Transaminase;Aspartate Aminotransferase/Alanine Transaminase Ratio;Alkaline Phosphatase;Total bilirubin;Liver fattyization, liver fibrosis measured from Fibroscan;Liver Disease Quality of Life;Total Cholesterol, Triglyceride, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol;Fatty Liver Index, Aspartate Aminotransferase to Platelet Ratio Index, The Fibrosis-4 score