A 12 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of NIHHS-19-01 on improving liver functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004797
- Lead Sponsor
- Chosun University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1.In the blood test, the ?-GTP exceeds the normal level of the laboratory and is within 3 times the normal upper limit.
2.In drinking habit survey, average male 14 units, female 7 units or more per week for the past month
Have alcohol habits
3. A person who agrees to participate in this human body test and writes a written consent before the human body test begins.
1) Those who are hospitalized, drug, rehabilitation treatment due to alcohol use / induced disorder, heart disease, central nervous disorder, etc.
2) Patients with liver cirrhosis or liver cancer on abdominal ultrasonography
3) Those who have AST (GOT) or ALT (GPT) more than 3 times normal upper limit in blood test
4) Those whose ALP is at least 3 times the upper limit or Platelet 105 / µL or less or AFP is 10 ng / mL
Excess factor
5) Currently diagnosed with viral hepatitis
6) Person who is positive on HBs Ag or HCV Ab test in screening test
7) Albumin 3g / dl or less
8) Person whose Creatinine is 1.5 times higher than normal upper limit
9) Those who are being treated for thyroid disease
10) Drugs affecting liver function within 4 weeks of Visit 1 (anti-tuberculosis drugs, anticonvulsants, gout medications,
Antidepressants, other drugs that may cause hepatotoxicity)
11) Those who have taken NSAIDs, antivirals or antibiotics within 2 weeks of Visit 1
12) Choleagogues, Cholelitholytics & Hepatoprotectants within 4 weeks of Visit 1
Hepatic Protectors, Antidote, Drug-Dependent Therapies (Antidotes, Detoxifying Agents &
Drugs Used in Substance Dependence
13) Herbal medicine, Vit. E Supplements or dietary supplements related to liver function improvement
Taker
14) Those who have taken corticosteroids or sex hormones within 4 weeks of visit 1
15) Patients with uncontrolled hypertension (more than 160 mmHg systolic blood pressure or 100 mmHg diastolic blood pressure)
Above, after 10 minutes of stabilization of human subjects
16) Uncontrolled diabetics (HbA1C> 7.0%)
17) Those who newly received anti-lipid drug within 3 months of visit1 (during 3 months before)
If you are)
18) Those who complain of severe gastrointestinal symptoms such as heartburn or indigestion
19) Pregnant or have a pregnancy plan during this human testing period.
20) within one month of the start of this human trial, into another interventional clinical trial (including human trials).
Participated in, or entered other interventional trials (including human trials) after the start of this human trial.
Have a plan to participate
21) A person who judges that it is inappropriate for this human application test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?-GTP
- Secondary Outcome Measures
Name Time Method AST, ALT ,AST/ALT ratio , MFS , TC, TG, HDL-C, LDL-C