Clinical trial NCT00976274: Korean Red Ginseng and Metabolic Syndrome
Official title: Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Korean red ginseng
metabolic syndrome
blood pressure
arterial stiffness
inflammation
oxidative stress
Lead sponsor: The Korean Society of Ginseng
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in the Pre- and Post-treatment Systolic Blood Pressure
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Univeristy College of Medicine, Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University College of Medicine Gangnam severance Hospital
name: Jae-Yong Shim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.