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Ginsenoside Improve Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Dong-Hyuk Jung, CHA University.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: January 13, 2014
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The Korean Society of Ginseng
Information provided by (Responsible Party):
Dong-Hyuk Jung, CHA University

Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose.

Randomized Control Trial.

Condition Intervention
Metabolic Syndrome Dietary Supplement: Ginsenoside Dietary Supplement: Dietary fiber fill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Dong-Hyuk Jung, CHA University:

Primary Outcome Measures:
  • Change from baseline in metabolic syndrome profile at week 4 [ Time Frame: Baseline and 4 weeks from intake of Ginsenoside ]
    Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight

Secondary Outcome Measures:
  • Change from baseline in hormones at week 4. [ Time Frame: Initial and 4 weeks later ]
    insulin ,cortisol, testosterone, somatomedin-c and DHEAS

Other Outcome Measures:
  • Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginsenoside

Ginsenoside :

Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group

Dietary Supplement: Ginsenoside
3.0 g/ d for 28 days
Other Name: Ginseng fill
Placebo Comparator: Dietary fiber fill
Dietary fiber fill manufactured to mimic Ginsenoside tablet
Dietary Supplement: Dietary fiber fill
3g/day, 28days

Detailed Description:

Methods : A randomized, double-blind, placebo-controlled, single-center study in 60 subjects who are not taking drugs that could affect metabolic and vascular function. Subjects will be randomized into a Korean red ginseng (3.0g/d) group or placebo group for a 4-week study.

We will collect anthropometric measurements, blood for laboratory testing, inflammatory marker, hormones and mitochondrial DNA copy number.

Subject : Older than 40 years of age, presented with metabolic syndrome. Subjects were excluded if they were taking drugs that could affect metabolic and vascular function, including BP control drug, anti-diabetic drugs and lipid-lowering drugs.

Measurement : We will collect anthropometric measurements and blood for laboratory testing at the initial(week 0) and final (week 4)visits. Serum levels of blood glucose, insulin, total cholesterol, HDL-cholesterol,triglyceride, and DNA copy number of mitochondria.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

  • Taking drug for lipid-lowering, BP control and anti-diabetic.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034136

Contact: DH Jung, MPH +82) 10-4204-8998 balsan2@empas.com
Contact: YJ Lee, Ph.D +82) 3015-2011 ykyjhome@yuhs.ac

Korea, Republic of
Bundang CHA Hospital Not yet recruiting
Seoul, Kyeonggi-do, Korea, Republic of
Contact: HG Park, PhD       irb@chamc.co.kr   
Principal Investigator: DH Jung, MPH         
Sponsors and Collaborators
CHA University
The Korean Society of Ginseng
Principal Investigator: DH Jung, MPH.M.D. Cha Medical University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong-Hyuk Jung, Assistant professor, Family medicine, CHA University
ClinicalTrials.gov Identifier: NCT02034136     History of Changes
Other Study ID Numbers: DH-13722
BD2013-104 ( Other Identifier: Cha medical university IRB )
First Submitted: July 21, 2013
First Posted: January 13, 2014
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases