A human study for evaluation of effectiveness and safety of Perilla frutescens Britton extract consumption on improving hepatoprotective and antioxidative capacity

A randomized, double-blind, placebo-controlled study for evaluation of effectiveness and safety of Perilla frutescens Britton extract consumption on improving hepatoprotective and antioxidative capacity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000911

Enrollment

Registered

2013-11-06

Start date

2013-10-21

Completion date

Unknown

Last updated

2019-03-11

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 : Consumption of placebo or Perilla frutescens Britton extract for 10 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agrees to participate and signs in informed consent form 2) Age: = 20 years 3) BMI: = 25kg/m2 and = 35kg/m2 4) ALT or AST: = the upper limit of normal levels(ULN)?1.5 and < ULN?5

Exclusion criteria

Exclusion criteria: 1) Chronic smoker (= 20 cigarettes/d) 2) Heavy drinker(= 420g/week) 3) Subject with following diseases and past medical history ? viral hepatitis, liver dysfunction, serious liver disease, primary biliary cirrhosis, drug-induced liver disease, autoinnune liver disease, inherited liver disease ? General infectious disease (included tuberculosis), serious CVD, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, ulcerative colitis, uncontrolled mental illness, HIV 4) Received organ transplantation or bone marrow transplantation 5) Predicted to use prohibited drugs 6) Administration of drugs that affect liver function within 6 months before the first visit or administration of steroid over 14 days 7) Consumption of dietary supplements or oriental medicine that affect liver function and antioxidative capacity within 8 weeks before the first visit 8) Subjects with hypersensitivity to test materials 9) Participation in other human study within 12 weeks before the first visit 10) Pregnant or lactating women 11) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
Markers of hepatic function	—

Secondary

Measure	Time frame
Antioxidative markers, etc.	—

Countries

Korea, Republic of

Contacts

Public ContactJieun Park

Ewha Womans University

Outcome results