Hypertension, Stage I, Prehypertension
Conditions
Keywords
Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity
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. control group (placebo), low dose Ginseol Kg1 group (100mg), or high dose Ginseol Kg1 (300mg) group. They will intake the study drug for 8 weeks. 24-h ambulatory BP monitoring (ABPM) and pulse wave velocity are measured at the end of the washout period and after 8 weeks of active treatment. At each visit, seated SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded. Compliance with medication (determined by counting returned tablets) is evaluated at each visit.
Interventions
DRUGGinseol Kg1 (low dose)
1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks
DRUGGinseol Kg1(high dose)
1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
DRUGPlacebo
1 capsule/day (starch), Duration: 8 weeks
Sponsors
DongGuk University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group | baseline and 8 week |
Secondary
| Measure | Time frame |
|---|---|
| The difference of the changes in the mean 24-hour ambulatory systolic and diastolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group. | baseline and 8 week |
| The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group. | baseline and 8 week |
| The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group. | baseline and 8 week |
| The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group | baseline and 8 week |
| The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group. | baseline and 4 week |
Countries
South Korea
Contacts
Primary ContactKwang-il Kim, MD, PhD
Outcome results
None listed