Effect of Ginseol Kg1 on Blood Pressure Lowering

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Hypertension, Stage I; Prehypertension

Treatments: Drug: Ginseol Kg1 (low dose); Drug: Placebo; Drug: Ginseol Kg1(high dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT01483430

CJ_Ginseol Kg1

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Ginseol Kg1, high dose

Experimental group

Treatment:

Drug: Ginseol Kg1(high dose)

Ginseol Kg1, low dose

Experimental group

Treatment:

Drug: Ginseol Kg1 (low dose)