Korean Red Ginseng and Metabolic Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-01-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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starch capsule

Group Type PLACEBO_COMPARATOR

starch

Intervention Type DIETARY_SUPPLEMENT

5 capsules three times everyday for 12 weeks

Korea red ginseng

Group Type EXPERIMENTAL

Korean red ginseng

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Korean red ginseng

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

Intervention Type DIETARY_SUPPLEMENT

starch

5 capsules three times everyday for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Korean Red Ginseng Powder Capsule, KGC1039012 KGC1039015

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No