Effect of Ginseol Kg1 on Blood Pressure Lowering

Phase 3

• Conditions: Prehypertension; Hypertension, Stage I
• Interventions: Drug: Placebo; Drug: Ginseol Kg1(high dose); Drug: Ginseol Kg1 (low dose)

• Registration Number: NCT01483430
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-11
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-29
• Last Update Submitted: 2011-11-30
• Study First Posted: 2011-12-01
• Last Update Posted: 2011-12-02
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ginseol Kg1, high dose	Ginseol Kg1(high dose)	-
Ginseol Kg1, low dose	Ginseol Kg1 (low dose)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of