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Effect of Ginseol Kg1 on Blood Pressure Lowering

Primary Purpose

Prehypertension, Hypertension, Stage I

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ginseol Kg1 (low dose)

Ginseol Kg1(high dose)

Placebo

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ginseol Kg1, high dose

Ginseol Kg1, low dose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.

The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.

The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group

The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.

Full Information

NCT ID

NCT01483430

First Posted

November 29, 2011

Last Updated

November 30, 2011

Sponsor

Seoul National University Hospital

Collaborators

DongGuk University

1. Study Identification

Unique Protocol Identification Number

NCT01483430

Brief Title

Effect of Ginseol Kg1 on Blood Pressure Lowering

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

DongGuk University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prehypertension, Hypertension, Stage I

Keywords

Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Ginseol Kg1, high dose

Arm Type

Experimental

Arm Title

Ginseol Kg1, low dose

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ginseol Kg1 (low dose)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ginseol Kg1(high dose)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

baseline and 8 week

Secondary Outcome Measure Information:

Title

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.

Time Frame

baseline and 8 week

Title

The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.

Time Frame

baseline and 8 week

Title

The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.

Time Frame

baseline and 8 week

Title

The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group

Time Frame

baseline and 8 week

Title

The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.

Time Frame

baseline and 4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kwang-il Kim, MD, PhD

Phone

+82-31-787-7032

kikim907@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwang-il Kim, MD, PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kwang-il Kim, MD, PhD

Phone

+82-31-787-7032

kikim907@snu.ac.kr

12. IPD Sharing Statement

Citations:

PubMed Identifier

24871654

Citation

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.

Results Reference

derived

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Effect of Ginseol Kg1 on Blood Pressure Lowering

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