Effect of Ginseol Kg1 on Blood Pressure Lowering

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

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

Study Overview

• Status: Unknown
• Conditions: Prehypertension; Hypertension, Stage I
• Intervention / Treatment: Drug: Placebo; Drug: Ginseol Kg1(high dose); Drug: Ginseol Kg1 (low dose)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Kwang-il Kim, MD, PhD; Phone Number: +82-31-787-7032; Email: kikim907@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: DongGuk University
• Investigators: Principal Investigator: Kwang-il Kim, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2011
• Last Update Submitted That Met QC Criteria: November 30, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Blood pressure; Pulse wave velocity; Ambulatory blood pressure; Korea red ginseng
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: CJ_Ginseol Kg1