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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002713
Enrollment
80
Registered
2018-03-02
Start date
2017-01-25
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Intake 2 capsules / once a day after breakfast for 12 weeks. • Experimental Period visit 1, visit 2, each 42 day • Experimental group once a day, 2 capsules / time (600 mg/d

Sponsors

Chonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Systolic Blood Pressure;Distolic Blood Pressure

Secondary

MeasureTime frame
Mean Blood Pressure;Pluse Pressure;Renin activity;Aldosterone;hs-CRP;Nitrc oxide;Pulse Rate;Advers event monitoring;Clinical pathological test;Physical examination;Electrocardiogram

Countries

Korea, Republic of

Contacts

Public ContactKIM RIM

Chonbuk National University Hospital

wrkim@jbctc.org+82-63-259-3052

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026