Effect of Ginseol Kg1 on Blood Pressure Lowering

Seoul National University Hospital90 enrolled

Overview

In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood pressure in prehypertensive or stage I hypertensive patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Prehypertension Hypertension, Stage I

Interventions

Ginseol Kg1 (low dose)DRUG

1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks

Ginseol Kg1(high dose)DRUG

1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks

PlaceboDRUG

1 capsule/day (starch), Duration: 8 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group