Pinus koraiensis leaves combination for improvement of liver function

A randomized, double-blind, placebo-controlled clinical trial to the efficacy of Pinus koraiensis leaves combination on improving liver function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005331

Enrollment

Registered

2020-08-24

Start date

2019-04-25

Completion date

Unknown

Last updated

2020-09-07

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 : Pinus koraiensis leaves combination or Placebo, 500mg/capsule Capsules, 500mg/capsule, 3 capsules/time, Twice a day, Oral administration for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 19 to 65 years old 2) Men who usually drink over 14 units and women who usually drink over 7 units a week 3) A person who agrees to participate in the study voluntarily and sign the informed consents

Exclusion criteria

Exclusion criteria: 1) Men who drink over 40g of alcohol or women who drink over 20g of alcohol every day 2) A person whose laboratory test results in any of the following at the screening visit - AST, ALT, GGT, ALP, LDH = over 2 times normal upper limit - AST/ALT ratio = 2 - platelet count = 100,000/µL or AFP = 20ng/mL 3) A person with uncontrolled diabetes or hypertension: fasting glucose = 180mg/dL or SBP/DBP = 160/100mmHg 4) A person diagnosed with thyroid disease 5) Underweight or Obesity (BMI < 18.5 kg/m2 or BMI = 30.0 kg/m2) 6) Pregnancy or breast feeding women or women who has a plan pregnancy or breast feeding 7) A person who has treated with the following medical histories: alcohol use disorder, heart disease, central nerve disorder, drug addiction 8) A person defined as alcohol use disorder by AUDIT-K questionnaire 9) A person diagnosed with viral hepatitis or acute hepatitis or liver cirrhosis or liver cancer 10) A person with the following medical histories: renal dysfunction (creatinine level over 1.5 times normal upper limit), malignant tumors, mental disorder, heart disease, digestive disease, biliary disease, autoimmune disease, or mental diseases. 11) A person who consistently has taken medicine, herb medicine, or supplements to improve liver function within 3 months prior to the screening visit 12) A person who has taken medicine causing liver toxicity in a month prior to the screening visit 13) A person who has been taking medicine for diabetes, hyperlipidemia within 3 months prior to the screening visit 14) A person who has participated in other clinical studies within 1 month prior to the screening visit 15) A person with allergy or hypersensitivity to ingredients of investigational product. 16) A person who has any other inappropriate reasons to participate in the study as judged by the investigators

Design outcomes

Primary

Measure	Time frame
Aspartate aminotransferase (ALT)	—

Secondary

Measure	Time frame
Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT), %Carbohydrate-deficient transferrin (%CDT), AST/ALT ratio;Triglyceride (TG), Total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), Free fatty acid (FFA);Superoxide dismutase (SOD), Catalase;Fatigue Severity Scale (FSS);Blood pressure, pulse rate, body temperature;Laboratory test;Adverse event	—

Measure

Time frame

Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT), %Carbohydrate-deficient transferrin (%CDT), AST/ALT ratio;Triglyceride (TG), Total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C), Free fatty acid (FFA);Superoxide dismutase (SOD), Catalase;Fatigue Severity Scale (FSS);Blood pressure, pulse rate, body temperature;Laboratory test;Adverse event

—

Countries

Korea, Republic of

Contacts

Public ContactJuhyun Park

Research Institute of Medical Nutrition

Outcome results