efficacy and safety of Aralia elata seem. extract powder in the evaluation of on blood pressure improving : 12 weeks, randomized, double-blind, placebo-controlled clinical trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002713
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Male and female subject aged between 19 years and 65 years.
2) subjects who without a medical history of high blood pressure in within the last 3 months and SBP 120~149mmHg or DBP 85~94mmHg
3) subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
1) subjects who more than SBP 150mmHg or DBP 95mmHg
2) subjects who correspond to high risk group about cerebrovascular and cardiovascular disease incidence risk (more than ASCVD risk 15%)
3) subjects who intake antihypertensive agent within the last 3 months
4) subject who get diagnosed secondary hypertension
5) subject who get surgery of coronary arterioplasty, coronary artery bypass graft through transdermal to treat for cerebrovascular and cardiovascular disease within the last 6 months.
6) subjects who have acute severe cerebrovascular and cardiovascular disease such as heart failure, myocardial infarction, stroke.
7) subjects who have renal disease such as acute chronic renal failure and nephrotic syndrome
8) subjects who have acute/chronic inflammatory such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease
9)
10) subjects who have hypersensitivity with drug or funtional foods
11) subject who get a medical history of psychopharmacotherapy with in last 2 months before screening test
12) subject who are dependent on drugs or alcohol
13) subject who participated in any clinical trial within 2 months before screening test
14) subject who show the following results at the test
(AST, ALT )
15) subjects who are pregnant and breastfeeding female
16) subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation)
17) subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure;Distolic Blood Pressure
- Secondary Outcome Measures
Name Time Method Mean Blood Pressure;Pluse Pressure;Renin activity;Aldosterone;hs-CRP;Nitrc oxide;Pulse Rate;Advers event monitoring;Clinical pathological test;Physical examination;Electrocardiogram