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

A human study for evaluation of the effect of Angelica keiskei koidzum on improving hepatic function and satety

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003676

Enrollment

Registered

2019-03-27

Start date

2019-03-30

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects take placebo or Angelica keiskei koidzum 3 times a day(3 capsules/time) for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Hepatic function related markers(alanine aminotransferase,aspartate aminotransferase,gamma glutamyltranspeptidase )	—

Secondary

Measure	Time frame
Hematological test(White blood cell, Red blood cell, Hemoglobin)	—

Countries

Korea, Republic of

Contacts

Public ContactSeong Hwang

Bundang CHA General Hospital

sghwang@hanmail.net+82-31-780-5213

Outcome results