Clinical trial for the evaluation of the efficacy and safety of NIHHS-18-42458 on improving liver functio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004392
- Lead Sponsor
- ational Institute of Horticultural and Herbal Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Adult male and female between 19-75 years 2) 50 IU/L =
AST or ALT = 120 IU/L 3) Subject who voluntarily agrees to participate and sign
in informed consent form
1) Subject who are admitted to hospital, medication or
rehabilitation due to alcohol use disorder ? related disorder, heart disease,
central nervous disorder, etc 2) Abdominal ultrasound exam showed liver
cirrhosis or liver cancer patients 3) Subject who more than 3times the upper
limit of normal ?-GTP 4) Subject who more than 3times the upper limit of normal
ALP or Platelet = 10^5/µL or AFP > 10ng/mL 5) Subject who have been diagnosed
with viral hepatitis 6) Subjcet who were positive HBs Ag or HCV Ab in screening
test 7) Subject who Albumin = 3g/dl or Total Bilirubin = 3mg/dl 8) Subject who
more than 1.5times the upper limit of normal Creatinine 9) Uncontrolled thyroid
disease patient 10) Subject who was taking drugs the affects liver function
within 4 weeks of study(antituberculosis drugs, anticonvulsants, arthrifuges,
antidepressants and other drugs that may cause hepatotoxicity) 11) Subject who
was taking NSAIDs, antiviral agents, antibiotics within 2 weeks of study 12)
Subject who was taking cholagogues, Cholelitholytics & Hepatic Protectors,
antidotes, Detoxifying Agents & Drugs Used in Substance Dependence within 4
weeks of study 13) Subject who was taking herbal medicine, Vitamine.E
supplements, and health functional foods related to liver function improvement
within 2 weeks of study 14) Subject who was taking corticosteroids or sex
hormones within 4 weeks of study 15) Patients with uncontrolled
hypertension(systolic BP = 160 mmHg or diastolic BP = 100 mmHg, measurement
after stabilization for 10 minutes of test subjects 16) Uncontrolled
diabetic(fasting blood glucose = 180mg/dl) 17) Subject who have dosed
Anti-phospholipid drugs within 3 months (They can participate if they have been
on treatment since 3 months) 18) Subject who have immoderate drinking habits 19)
Subject who have severe gastrointestinal symptoms such as heartburn,
indigestion, etc. 20) Subject who are sensitive or allergic to testing food for
this human 21) Subject who is pregnant or has a pregnancy plan during the period
of the clinical trial 22) Subject who has planned to participate in other
clinical trials during the clinical trial study 23) Subject who have
participated other clinical trials within the past month 24) Subject who the
opinion investigator make a judgment to be unsuitable
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of AST, ALT
- Secondary Outcome Measures
Name Time Method AST, ALT rate of change;Change of ?-GTP;AST/ALT ratio;Multidimensional Farigue Scale(MFS);Total Cholesterol, Triglyceride , HDL-Cholesterol, <br>LDL-Cholesterol;Adverse events;clinical laboratory test(hematologic/chemistry examination, <br>Urinalysis);Vital Sign(pulsus, arteriotony) , Physical measurement <br>(Weight);electrocardiography