- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976274
Korean Red Ginseng and Metabolic Syndrome
Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With 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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-720
- Yonsei Univeristy College of Medicine, Gangnam Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: starch capsule
|
5 capsules three times everyday for 12 weeks
Other Names:
|
EXPERIMENTAL: Korea red ginseng
|
5 capsules (300 mg/capsule) three times everyday for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Pre- and Post-treatment Systolic Blood Pressure
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jae-Yong Shim, Ph.D., Yonsei University College of Medicine Gangnam severance Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-2009-0015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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