A human study for evaluation of the effect of Angelica keiskei koidzum on improving hepatic functio

Not Applicable

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003676
• Lead Sponsor: KINDSBIOTIX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1) Subject who voluntarily agrees to participate and signs in informed consent form
2) 20 = Age < 75 years
3) normal range = GGT(gamma glutamyltranspeptidase)
4) the upper limit of normal levels?1.5 < one or more of ALT(alanine aminotransferase) or AST( aspartate aminotransferase)
5) intake of alcohol: male = 210 g / week, female = 105 g / week

Exclusion Criteria

1) alcoholics
2) Subject with following diseases and past medical history
? diseases related hepatic function
? infectious disease, serious cardiovascular disease, disease of digestive system,
renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure,
Inflammatory Bowel Disease, serious mental illness,HIV positive
? who has continuous symptom releated with gastrointestinal diseases
3) Received organ transplantation or bone marrow transplantation
4) Be applicable to one or more
- one or more of AST( aspartate aminotransferase), ALT(alanine aminotransferase), GGT(gamma glutamyltranspeptidase), ALP(alkaline phosphatase), LDH(lactate dehydrogenase) = the upper limit of normal levels(ULN)?3
- Platelet = 105/mL or a-fetoprotein > 20 ng/mL
- Albumin =3.0 g/dL or total bilirubin = 3 mg/dL
- Creatinine = the upper limit of normal levels(ULN)?2
5) Administration of drugs that affect liver function within 12 weeks before the first visit
6) Subjects with High quality of the meal
7) Predicted to use prohibited drugs
8) Continuous consumption of dietary supplements or oriental medicine within 4 weeks before the
first visit
9) Subjects with hypersensitivity to test materials
10) Participation in other human study within 12 weeks before the first visit
11) Pregnant or lactating women
12) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic function related markers(alanine aminotransferase,aspartate aminotransferase,gamma glutamyltranspeptidase )

Secondary Outcome Measures

Name	Time	Method
Hematological test(White blood cell, Red blood cell, Hemoglobin)