Efficacy and safety evaluation study of Oryeongsan for stage I primary hypertensio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009705
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1) Aged = 19 years old
2) Before Randomized, if either of the following applies
- 140 mmHg =MSSBP < 160 mmHg
- 90 mmHg = MSDBP < 100 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in SBP in experimental group and control group;Amount of change in DBP in experimental group and control group;rates of patients achieving a therapeutic goal in the two groups at termination;blood pressure response rates in the two groups at termination
- Secondary Outcome Measures
Name Time Method Amount of change in health-related quality of life;liver and renal function test