None listed
Conditions
Interventions
Drug : The experimental group was received Oryung-san Extract Granules and placebo group was received control capsules. The subjects take test material or placebo three times a day, each time 2
capsu
Sponsors
Woosuk University Korean Medicine Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged = 19 years old 2) Before Randomized, if either of the following applies - 140 mmHg =MSSBP < 159 mmHg - 90 mmHg = MSDBP < 99 mmHg 3) Those who are not currently taking anti-hypertensive medication and who have not taken medication for hypertension within the last 4 weeks 4) Those who have the ability and willingness to voluntarily agree to take part in the clinical trial and participate in the test
Exclusion criteria
Exclusion criteria: 1) At screening and randomized, MSSBP = 160 mmHg or MSDBP = 100 mmHg 2) At screening, SSBP difference is = 20 mmHg and SDBP difference= 10mmHg 3) Known or suspected secondary hypertension(ex. aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease) 4) Patients with orthostatic hypotension with symptoms 5) Unregulated diabetes (Excluding patients who do not need diabetes medication during the study period) 6) Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG) 7) Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia 8) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, immunologically significant aortic or mitral stenosis 9) Subject with severe cerebrovascular disease (infarct, hemorrage) ithin recent 6 months. 10) known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months) 11) Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous 12) There is clinically significant kidney or liver disease defined by the following laboratory parameters: - renal dysfunction(CCr < 30 mL/min, Serum creatinine = 2 mg/dL or UNL X 1.5) - hepatic dysfunction(AST/ALT = UNL X 3) 13) Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion 14) Patients who are dependent on drugs or alcohol 15) Childbearing and breast-feeding women, A female patient whose pregnancy was confirmed by a pregnancy test of urine specimen. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods 16) chronic inflammatory status need to treatment 17) Persons with known or suspected hypersensitivity reactions to the test substance or the same class of drug 18) Those who participated in other studies within 3 months before screening. 19) Those who drank on the day of study participation, those who consumed caffeine drinks within 1 hour 20) Subject who the opinion investigator make a judgment to be unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in systolic blood pressure change before and after treatment, difference in diastolic blood pressure change before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in systolic and diastolic pressure change before and after treatment;Blood pressure normalization rate;Blood pressure response rate;EQ-5D (EuroQol-five Dimensions questionnaire);Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactGihyang Lee
Woosuk University Korean Medicine Medical Center
Outcome results
None listed