Clinical trial NCT01483430: Effect of Ginseol Kg1 on Blood Pressure Lowering
Official title: Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prehypertension
Hypertension, Stage I
Keywords: Blood pressure
Korea red ginseng
Ambulatory blood pressure
Pulse wave velocity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: DongGuk University
First posted: 2011-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group
timeFrame: baseline and 8 week
Secondary outcomes:
measure: 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.
timeFrame: baseline and 8 week
measure: The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.
timeFrame: baseline and 8 week
measure: The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.
timeFrame: baseline and 8 week
measure: The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group
timeFrame: baseline and 8 week
measure: The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.
timeFrame: baseline and 4 week
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kwang-il Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396.