Effect of Ginseol Kg1 on Blood Pressure Lowering

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study

Conditions
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Prehypertension, Hypertension, Stage I

Intervention / Treatment
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* Drug: Ginseol Kg1 (low dose)
* Drug: Ginseol Kg1(high dose)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 capsule/day (starch), Duration: 8 weeks<br>|
| Experimental: Ginseol Kg1, high dose<br> | Drug: Ginseol Kg1(high dose)<br>* 1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks<br>|
| Experimental: Ginseol Kg1, low dose<br> | Drug: Ginseol Kg1 (low dose)<br>* 1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity