Korean Red Ginseng and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976274
• Other study ID #: 3-2009-0015
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: February 23, 2012
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: The Korean Society of Ginseng
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Korean red ginseng
5 capsules (300 mg/capsule) three times everyday for 12 weeks
• starch
5 capsules three times everyday for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Univeristy College of Medicine, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Pre- and Post-treatment Systolic Blood Pressure		baseline and 12 weeks	No
Secondary	Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)		baseline and 12 weeks	No