Status:
UNKNOWN
Effect of Ginseol Kg1 on Blood Pressure Lowering
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
DongGuk University
Conditions:
Prehypertension
Hypertension, Stage I
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood pressure in prehypertensive or stage I hypertensive patients.
Detailed Description
This is a multicenter, randomized, placebo-controlled, double-blind study. At the end of an initial 2-week washout period, patients fulfilling the inclusion criteria are assigned to three groups, i.e....
Eligibility Criteria
Inclusion
- Age: Adults over 20 years
- Prehypertension or stage 1 hypertension (systolic blood pressure 120\~159mmHg or diastolic blood pressure 80\~99mmHg)
- Subject who has not taken medications to treat hypertension within 15 days prior to first visit
Exclusion
- Subject who has been involved in other clinical trials within 30 days prior to first visit
- Subject who has following diseases within 2 years prior to screening: angina pectoris, myocardial infarction, heart failure, peripheral vascular disease, chronic liver failure, chronic renal failure, diabetes mellitus, hyperthyroidism, hypothyroidism, malignant tumor, mental disease
- Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100 mmHg during screening period
- Subject who has hepatic dysfunction(AST, ALT ≥ 2.5 times higher than normal value)
- Subject who has renal dysfunction(creatinine ≥ 1.5 times higher than normal value)
- Subject who is pregnant or breast feeding
- Alcoholic
- Subject who has an allergy to the ingredients of study product
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01483430
Start Date
September 1 2011
End Date
December 1 2012
Last Update
December 2 2011
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707