None listed
Conditions
Interventions
Dietary Supplement : - Control group 50: placebo comparator/ Intake 4 placebo tablets twice daily before meals (breakfast, dinner) for 8 weeks
- Experimental group 50: experimental/ Intake 4 tablets
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subject aged between 19 years and 70 years 2) Subject with mean sitSBP 120~139 mmHg and mean sitDBP 80~89 mmHg at screening (at least 2 times measurements, 2-minute interval) 3) Subject who agrees to participate in the study and signs the informed consent form
Exclusion criteria
Exclusion criteria: 1) Subject who cannot discontinue antihypertensive drugs 2) Subject taking a drug influence of blood pressure (Steroid, Thyroid hormone, Contraceptive pills, Central nervous system depressants or stimulants, Angina pectoris drugs, Immunosuppressant, Blood Thinners etc.) over 3 months 3) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose at screening) 4) Subject with severe cerebrovascular disease (stroke, cerebral infarction, cerebral hemorrhage) within 6 months 5) Subject with severe heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia that needs medical treatments) 6) Patients who are dependent on drugs or alcohol 7) Subject with Creatinine = 2 times the upper limit of normal 8) Subject with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = 3 times the upper limit of normal 9) Subject who is pregnant, lactating or planning to pregnant during this clinical trial 10) Subject planning to participate in the other clinical study 11) Subject participated in any clinical trial within 3 months 12) Inappropriate subject decided by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of blood pressure (systolic, diastolic, mean arterial pressure) level ;adverse reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Renin activity level;Change in ACE(Angiotensin-converting enzyme ) activity level;Change in Homocysteine level;Change in hs-CRP(high-sensitivity C-reactive protein) level;Change in PAI-1(Plasminogen activator inhibitor-1) level ;Ratio of patients reaching systolic blood pressure level below 120 mmHg;Ratio of patients reaching diastolic blood pressure level below 80 mmHg;change of pulse rate;change of body weight | — |
Countries
Korea, Republic of
Contacts
Public Contactsu nam
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed