Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The details of study objective are followed by these:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| starch capsule | Placebo Comparator |
| |
| Korea red ginseng | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean red ginseng | Dietary Supplement | 5 capsules (300 mg/capsule) three times everyday for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pre- and Post-treatment Systolic Blood Pressure | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | baseline and 12 weeks |
Not provided
Inclusion Criteria:(three or more of following five factors)
Exclusion Criteria: (any one of following factors)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jae-Yong Shim, Ph.D. | Yonsei University College of Medicine Gangnam severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Univeristy College of Medicine, Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22916320 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Starch Capsule | 5 capsules three times everyday for 12 weeks |
| FG001 | Korea Red Ginseng | 5 capsules (300mg/capsule) three times everyday for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Starch Capsule | 5 capsules three times everyday for 12 weeks |
| BG001 | Korea Red Ginseng | 5 capsules (300mg/capsule) three times everyday for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Pre- and Post-treatment Systolic Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | baseline and 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Starch Capsule | 5 capsules three times everyday for 12 weeks |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jae-Yong Shim | Department of Family Medicine, Yonsei University College of Medicine | (+82) 2-2019-3480 | hope@yuhs.ac |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| starch | Dietary Supplement | 5 capsules three times everyday for 12 weeks |
|
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | Posted | Mean | Standard Deviation | uIU/mL | baseline and 12 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Korea Red Ginseng | 5 capsules (300mg/capsule) three times everyday for 12 weeks | 0 | 29 | 0 | 29 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |