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Korean Red Ginseng and Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Yong Shim, The Korean Society of Ginseng
ClinicalTrials.gov Identifier:
NCT00976274
First received: September 11, 2009
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Dietary Supplement: Korean red ginseng
Dietary Supplement: starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Korean Society of Ginseng:

Primary Outcome Measures:
  • Change in the Pre- and Post-treatment Systolic Blood Pressure [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: starch capsule Dietary Supplement: starch
5 capsules three times everyday for 12 weeks
Other Name: KGC1039015
Experimental: Korea red ginseng Dietary Supplement: Korean red ginseng
5 capsules (300 mg/capsule) three times everyday for 12 weeks
Other Name: Korean Red Ginseng Powder Capsule, KGC1039012

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976274

Locations
Korea, Republic of
Yonsei Univeristy College of Medicine, Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
The Korean Society of Ginseng
Investigators
Principal Investigator: Jae-Yong Shim, Ph.D. Yonsei University College of Medicine, Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: Jae-Yong Shim, Professor, The Korean Society of Ginseng
ClinicalTrials.gov Identifier: NCT00976274     History of Changes
Other Study ID Numbers: 3-2009-0015
Study First Received: September 11, 2009
Results First Received: January 19, 2012
Last Updated: February 23, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Korean Society of Ginseng:
Korean red ginseng
metabolic syndrome
blood pressure
 arterial stiffness
inflammation
oxidative stress

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013