None listed
Conditions
Interventions
Drug : Oral administration of Hwangryunhaedok-tang or placebo drug for 8 weeks, 3 times a day (3 grams at a time) before or between meals
Sponsors
Dunsan Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) adults aged 19 years or over but under 65 years at the screening visit (2) 130 mg/dl = baseline LDL cholesterol levels = 250 mg/dl (3) those who have voluntarily signed written informed consent approved by institutional review board, after sufficient explanation of this study
Exclusion criteria
Exclusion criteria: (1) having a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass surgery, coronary intervention or abdominal aneurysm within 3 months prior to screening (2) use of statins, ezetimibe, fibric acid derivatives, proprotein convertase subtilisin/kexin type 9 inhibitors, cholestyramine, nicotinic acid, omega-3 fatty acids, systemic steroids, diuretics, amiodarone, cyclosporin that can affect lipid profile within 4 weeks prior to screening (However, use of omega-3 fatty acids 4 g or less per day and short-term use of 6 mg or less per day of dexamethasone or equivalent corticosteroids within 5 days, which would not affect lipid levels, are allowed.) (3) uncontrolled hypertension with systolic blood pressure of more than 180 mmHg or diastolic blood pressure of more than 110 mmHg (4) uncontrolled diabetes mellitus with HbA1c of more than 9% or fasting blood glucose of more than 160 mg/dl (5) uncontrolled thyroid function (thyroid stimulating hormone (TSH) levels = 1.5 times upper limit of normal) (6) triglyceride levels of more than 500 mg/dl (7) severe liver or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal) (8) participants with a history of alcohol abuse or drug abuse within the past year (9) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial (10) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (11) participants with known hypersensitivity to investigational products (12) participants who had taken other investigational products within 3 months (13) participants who are thought to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| atherosclerosis biomarkers (hs-CRP, fibrinogen, homocysteine);other lipid parameter;arteriosclerosis test (baPWV, ABI);blood glucose parameter (fasting glucose, HbA1c);blood pressure;anthropometric parameter (body weight, body fat percentage, body fat mass, skeletal muscle mass, waist circumference, hip circumference,waist-to-hip ratio);health-related quality of life (EQ-5D-5L);Cold-heat pattern identification questionnaire;liver and renal function test (AST, ALT, BUN, Creatinine);adverse reaction;Intestinal microbial composition | — |
Countries
Korea, Republic of
Contacts
Public ContactBoram Lee
Korea Institute of Oriental Medicine
Outcome results
None listed