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

August 6, 2014 updated by: Jin Bae Lee, Daegu Catholic University Medical Center

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active(Korean Red Ginseng) first group:
Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Other Names:
  • Korean Red Ginseng (KRG) Capsule was manufactured
  • from roots of a 6-year-old Panax ginseng Meyer.
Placebo Comparator: Placebo capsules
placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Other Names:
  • Placebo of Kerea Red Ginseng(KRG) Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
central blood pressure change after treatment of Korea Red Ginseng
Time Frame: baseline, 8 weeks and 16 weeks after treatment
baseline, 8 weeks and 16 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
brachial systolic and diastolic blood pressure
Time Frame: baseline, 8 week, 16 week.
baseline, 8 week, 16 week.
Augumentation index
Time Frame: baseline, 8 week, 16 week.
baseline, 8 week, 16 week.
ESR(erythrocyte sedmentation rate)
Time Frame: baseline, 8 week, 16 week.
baseline, 8 week, 16 week.
CRP(C-reactive protein)
Time Frame: baseline, 8 week, 16 week.
baseline, 8 week, 16 week.

Other Outcome Measures

Outcome Measure
Time Frame
AST(Aspartate Aminotransferase)
Time Frame: baseline, 8 week, 16 week
baseline, 8 week, 16 week
Number of participants with adverse events
Time Frame: baseline, 8 week, 16 week
baseline, 8 week, 16 week
fasting blood glucose
Time Frame: baseline, 8 week, 16 week
baseline, 8 week, 16 week
Hb A1c(Hemoglobin A1c)
Time Frame: baseline, 8 week, 16 week
baseline, 8 week, 16 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jin Bae Lee, MD, PhD, Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • GS302-100 (Other Grant/Funding Number: GS302-100)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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