KCT0004797Recruiting未知
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 function
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Chosun University
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 75(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Investigators
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