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Completed

NCT Number: NCT00976274

Korean Red Ginseng and 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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei Univeristy College of Medicine, Gangnam Severance Hospital

Seoul, 135-720, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

5 capsules (300 mg/capsule) three times everyday for 12 weeks

Other names: Korean Red Ginseng Powder Capsule, KGC1039012

starch

Dietary Supplement

5 capsules three times everyday for 12 weeks

Other names: KGC1039015

Primary outcomes

  1. Change in the Pre- and Post-treatment Systolic Blood Pressure

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)

    Time frame: baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

The Korean Society of Ginseng

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2009
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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