None listed
Conditions
Interventions
Drug : Oral administration of Gyejibongnyeong-hwan or placebo drug 3 times a day (4 grams at a time) after every meal for 8 weeks
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged 19 years or over but under 65 years (2) Eligible subjects through screening tests and whose lipid profile result after 4 weeks of lifestyle modification correspond to one or more of the following: ? Total cholesterol 200 mg /dl or more, ? Triglyceride 150 - 499 mg/dL, ? LDL-cholesterol 130 - 250 mg/dL, ? HDL-cholesterol less than 40 mg/dL (But even if the subject corresponds to more than one, LDL-cholesterol should not exceed 250 mg/dL, and triglyceride should not exceed 499 mg/dL). (3) Those who have voluntarily signed written informed consent after sufficient explanation of this study
Exclusion criteria
Exclusion criteria: (1) Subjects who have a history of hypersensitivity or allergies to the components of study medication (2) Subjects who have a history of unstable angina, myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack, cerebrovascular disease, coronary artery disease, coronary artery bypass graft, percutaneous coronary intervention, peripheral arterial disease, carotid artery disease (significant carotid artery stenosis) or abdominal aneurysm; any malignant tumor within five years before screening; drug or alcohol abuse; gastrointestinal surgery or drug absorption disorders due to gastrointestinal disorders. (3) Subject with unstable hypertension (SBP = 180mmHg or DBP = 110mmHg); diabetes (whether taking diabetes medication or fasting blood glucose > 160 mg/dL ); AST or ALT = 2 x UNL; eGFR 2 x UNL or a history of myopathy or rhabdomyolysis; thyroidal disease; pancreatitis (4) Subjects who have administered a concomitant drug during the clinical trial period or who are judged to be unavoidable to administer a concomitant drug (5) Subjects who use drugs and food that can affect lipid profile within 4 weeks prior to the screening (statins, fibrates, bile acid sequestrants, niacin, anti-obesity drugs, steroids for systemic action, fish oil, omega-3, cholestin products, fiber-based laxatives, phytosterol margarine, etc.) (6) Subjects who have participated in other clinical trials within the last 3 months (7) Female subjects who are pregnant or lactating (8) Female subjects who plan to conceive (9) Subjects who the investigator considers to be inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes (%) in LDL-C from the baseline after 8-week treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes (%) in TC, HDL-C, TG, Apo A-I, Apo B from the baseline after 8-week treatment;other lipid parameters;The total score of Blood-Stasis questionnaire;liver and renal function test (AST, ALT, ?-GT, BUN, Creatinine);Adverse reaction;metabolites analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactByung-Cheol Lee
Kyung Hee University Oriental Medical Center
Outcome results
None listed