None listed
Conditions
Interventions
Drug : ? Investigator product
-Dashi-Ho-Tang: Hanpung Pharm.
-Control: Kunil Pharmaceutical's Omaco capsule is currently being used to treat triglycerides.
?Dosing period:
-Dashi-Ho-Tang: 3 times a d
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)19 years old and older-adults under 70 (2)Patients stably * regulate LDL-C levels by statin therapy for at least 2 months, but have triglyceride (TG) levels above 200 mg / dL and below 500 mg / dL (3)Cardiovascular High Risk Patients -Established cardiovascular disease (at least 50% narrowing on previous myocardial infarction, angina pectoris, coronary intervention, stroke, coronary and carotid imaging) -diabetes -Coronary Artery Disease Corresponding Risk. In other words, if the 10-year risk exceeds 20% and there are two or more risk factors (4)Fully understand the study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: Those who have a history of hypersensitivity or allergies to the components and analogues of the drug Persons with the following medical history or surgical history / procedure : Within 12 weeks: unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass surgery, coronary intervention : Malignant tumor within 5 years : Those who have had gastrointestinal surgery or have gastrointestinal disorders Persons with the following diseases and laboratory tests : Uncontrolled high blood pressure (SBP = 180mmHg or DBP = 110mmHg) : Uncontrolled diabetes (HbA1c = 9%) : AST or ALT = 2 x UNL : Renal dysfunction (Creatinine clearance 2 UNL or history of myopathy or rhabdomyolysis : Pancreatitis Applicants who have taken concomitant contraindications during the observation period or are deemed unavoidable to administer concomitant contraindications. Pregnant and lactating women Patients who do not agree to contraception Uncontrolled thyroid dysfunction (TSH> 1.5 UNL) Patients under 3 months of taking other investigational drugs Patients with a history of drug or alcohol abuse Those who are hypersensitive to the components of the investigational drug Those who have been treated to affect lipid levels prior to the trial (those who are taking the following drugs within 8 weeks are not allowed to participate in the study: HMG CoA reductase inhibitors, Ezetimibe, Fibrates (fibric acid derivatives): Bezafibrate, fenofibrate, gemfibrozil, bile acid binders, Nicotinic acid (niacin) and derivatives) Others judged to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change in TG, DG, TC, LDL-C, HDL-C, Apo AI, Apo B% change, baseline test and [LDL-C / HDL-C, TC] / HDL-C, Non-HDL-C / HDL-C, Apo B / Apo AI] rate of change (%), EndoPAT (vascular endothelial test) vs. control;Safety: Changes in liver function test (GOT, GPT, GGT) and renal function test (BUN, Cr) values were analyzed using t-test or the Wilcoxon rank sum test according to the normal distribution. Safety was observed when significant changes were observed or when significant differences were observed using the Chi-square test or Fisher's exact test for the incidence of adverse events and significant adverse events in the control and dashhotang groups. Judging from above | — |
Countries
Korea, Republic of
Contacts
Public ContactWeon Kim
Kyung Hee University Hospital
Outcome results
None listed