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Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension (KRGCBP)

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Korean Red Ginseng Capsules

Placebo

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring blood pressure, ginseng

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Essential hypertension
diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less

Exclusion Criteria:

Secondary hypertension
Serum creatinin above 1.5 mg/dL
aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits
Uncontrolled diabetes (Hb A1c < 9%)
Acute myocardial infarction or coronary artery disease intervention within six months
Moderate to severe congestive heart failure
HIV positive
Immunocompromized host
Allergy to Korean red ginseng
Pregnancy or plan to pregnancy
Alcohol or drug abuse
Attend to other clinical trial within 12 weeks

Sites / Locations

Daegu Catholic University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active(Korean Red Ginseng) first group:

Placebo capsules

Arm Description

Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week

Outcomes

Primary Outcome Measures

central blood pressure change after treatment of Korea Red Ginseng

Secondary Outcome Measures

brachial systolic and diastolic blood pressure

Augumentation index

ESR(erythrocyte sedmentation rate)

CRP(C-reactive protein)

Full Information

NCT ID

NCT02211352

First Posted

May 1, 2013

Last Updated

August 6, 2014

Sponsor

Daegu Catholic University Medical Center

Collaborators

The Korean Society of Ginseng

1. Study Identification

Unique Protocol Identification Number

NCT02211352

Brief Title

Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension

Acronym

KRGCBP

Official Title

Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Daegu Catholic University Medical Center

Collaborators

The Korean Society of Ginseng

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension.

Detailed Description

Participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over manner. Participants were not allowed to change their antihypertensive medications except safety issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at baseline,at 2 and 4 months. Efficacy and safety data will be monitored by Daegu Catholic University Medical Center Institutional Review Board and reported to the Korean Ginseng Society.

6. Conditions and Keywords

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

Hypertension

Keywords

blood pressure, ginseng

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active(Korean Red Ginseng) first group:

Arm Type

Active Comparator

Arm Description

Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Arm Title

Placebo capsules

Arm Type

Placebo Comparator

Arm Description

placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week

Intervention Type

Drug

Intervention Name(s)

Korean Red Ginseng Capsules

Other Intervention Name(s)

Korean Red Ginseng (KRG) Capsule was manufactured, from roots of a 6-year-old Panax ginseng Meyer.

Intervention Description

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo of Kerea Red Ginseng(KRG) Capsule

Intervention Description

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Primary Outcome Measure Information:

Title

central blood pressure change after treatment of Korea Red Ginseng

Time Frame

baseline, 8 weeks and 16 weeks after treatment

Secondary Outcome Measure Information:

Title

brachial systolic and diastolic blood pressure

Time Frame

baseline, 8 week, 16 week.

Title

Augumentation index

Time Frame

baseline, 8 week, 16 week.

Title

ESR(erythrocyte sedmentation rate)

Time Frame

baseline, 8 week, 16 week.

Title

CRP(C-reactive protein)

Time Frame

baseline, 8 week, 16 week.

Other Pre-specified Outcome Measures:

Title

AST(Aspartate Aminotransferase)

Time Frame

baseline, 8 week, 16 week

Title

Number of participants with adverse events

Time Frame

baseline, 8 week, 16 week

Title

fasting blood glucose

Time Frame

baseline, 8 week, 16 week

Title

Hb A1c(Hemoglobin A1c)

Time Frame

baseline, 8 week, 16 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Essential hypertension diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less Exclusion Criteria: Secondary hypertension Serum creatinin above 1.5 mg/dL aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits Uncontrolled diabetes (Hb A1c < 9%) Acute myocardial infarction or coronary artery disease intervention within six months Moderate to severe congestive heart failure HIV positive Immunocompromized host Allergy to Korean red ginseng Pregnancy or plan to pregnancy Alcohol or drug abuse Attend to other clinical trial within 12 weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Bae Lee, MD, PhD

Organizational Affiliation

Daegu Catholic University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Daegu Catholic University Medical Center

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

12. IPD Sharing Statement

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Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension

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