Korean Red Ginseng and Metabolic Syndrome

February 23, 2012 updated by: Jae-Yong Shim, The Korean Society of Ginseng

Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome

Five factor consisting of Metabolic syndrome is closely linked by insulin resistance. Until now, several studies have been performed about effects of Korea red ginseng on hypertension, diabetes, and hyperlipidemia, but not metabolic syndrome.

The investigators hypothesize that Korean red ginseng could improve each constituents of metabolic syndrome, arterial stiffness, and inflammatory markers.

The aim of this study is to determine effects of Korean red ginseng on cardiovascular risks in subjects with metabolic syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The details of study objective are followed by these:

  • comparison of blood pressure before and after Korean red ginseng administration
  • comparison of metabolic indicator before and after Korean red ginseng administration
  • comparison of oxidative stress and inflammatory markers before and after Korean red ginseng administration
  • comparison of arterial stiffness before and after Korean red ginseng administration

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Yonsei Univeristy College of Medicine, Gangnam Severance Hospital

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:(three or more of following five factors)

  • waist circumference(male: more than 90cm, female: more than 80cm)
  • blood pressure(systolic: more than 130mmHg, diastolic: more than 85mmHg)
  • fasting plasma glucose: more than 100mg/dL
  • fasting triglycerides: more than 150mg/dL
  • High-density lipoprotein(HDL)-cholesterol(male: less than 40mg/dL, female: less than 50mg/dL)

Exclusion Criteria: (any one of following factors)

  • uncontrolled blood pressure(systolic: more than 160mmHg, diastolic: more than 100mmHg) or subjects taking blood pressure lowering drug
  • Type 2 diabetes patients or fasting plasma glucose more than 126mg/dL
  • triglyceride more than 400mg/dL, total cholesterol more than 250mg/dL
  • subjects taking antilipidemic drug
  • past history of coronary heart disease or cerebrovascular disease

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: starch capsule
Dietary supplement: starch
5 capsules three times everyday for 12 weeks
Other Names:
  • KGC1039015
EXPERIMENTAL: Korea red ginseng
Dietary supplement: Korean red ginseng
5 capsules (300 mg/capsule) three times everyday for 12 weeks
Other Names:
  • Korean Red Ginseng Powder Capsule, KGC1039012

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Pre- and Post-treatment Systolic Blood Pressure
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

The Korean Society of Ginseng

Investigators

  • Principal Investigator: Jae-Yong Shim, Ph.D., Yonsei University College of Medicine Gangnam severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (ESTIMATE)

September 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2009-0015

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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