NCT00976274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 24, 2012

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

September 11, 2009

Results QC Date

January 19, 2012

Last Update Submit

February 23, 2012

Conditions

Metabolic Syndrome

Keywords

Korean red ginsengmetabolic syndromeblood pressurearterial stiffnessinflammationoxidative stress

Outcome Measures

Primary Outcomes (1)

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

    baseline and 12 weeks

Secondary Outcomes (1)

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

    baseline and 12 weeks

Study Arms (2)

starch capsule

PLACEBO COMPARATOR
Dietary Supplement: starch

Korea red ginseng

EXPERIMENTAL
Dietary Supplement: Korean red ginseng

Interventions

Korean red ginsengDIETARY_SUPPLEMENT

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

Also known as: Korean Red Ginseng Powder Capsule, KGC1039012
Korea red ginseng
starchDIETARY_SUPPLEMENT

5 capsules three times everyday for 12 weeks

Also known as: KGC1039015
starch capsule

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Univeristy College of Medicine, Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 22916320DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Interventions

Asian ginsengStarch

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Limitations and Caveats

First, we could not fully control participants' lifestyle such as exercise and diet.Second, the relationship between Korean red ginseng dosage and its effect on cardiovascular disease risks was not evaluated.

Results Point of Contact

Title
Dr. Jae-Yong Shim
Organization
Department of Family Medicine, Yonsei University College of Medicine
hope@yuhs.ac
(+82) 2-2019-3480

Study Officials

  • Jae-Yong Shim, Ph.D.

    Yonsei University College of Medicine Gangnam severance Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 27, 2012

Results First Posted

February 24, 2012

Record last verified: 2012-02

Locations

KR(1)