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Korean Red Ginseng and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean red ginseng
starch
Sponsored by
The Korean Society of Ginseng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei Univeristy College of Medicine, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

starch capsule

Korea red ginseng

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2009
Last Updated
February 23, 2012
Sponsor
The Korean Society of Ginseng
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1. Study Identification

Unique Protocol Identification Number
NCT00976274
Brief Title
Korean Red Ginseng and Metabolic Syndrome
Official Title
Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Korean Society of Ginseng

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
starch capsule
Arm Type
Placebo Comparator
Arm Title
Korea red ginseng
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Korean red ginseng
Other Intervention Name(s)
Korean Red Ginseng Powder Capsule, KGC1039012
Intervention Description
5 capsules (300 mg/capsule) three times everyday for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
starch
Other Intervention Name(s)
KGC1039015
Intervention Description
5 capsules three times everyday for 12 weeks
Primary Outcome Measure Information:
Title
Change in the Pre- and Post-treatment Systolic Blood Pressure
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Shim, Ph.D.
Organizational Affiliation
Yonsei University College of Medicine Gangnam severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Univeristy College of Medicine, Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22916320
Citation
Park BJ, Lee YJ, Lee HR, Jung DH, Na HY, Kim HB, Shim JY. Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects with Metabolic Syndrome: a Double-blind Randomized Controlled Study. Korean J Fam Med. 2012 Jul;33(4):190-6. doi: 10.4082/kjfm.2012.33.4.190. Epub 2012 Jul 25.
Results Reference
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Korean Red Ginseng and Metabolic Syndrome

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