Korean Red Ginseng and Metabolic Syndrome

• Sponsor: The Korean Society of Ginseng (Other)
• Overall Status: Completed
• CT.gov ID: NCT00976274
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: Korean red ginseng; Dietary Supplement: starch	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: starch capsule	Dietary Supplement: starch; 5 capsules three times everyday for 12 weeks; Other Names: KGC1039015
Experimental: Korea red ginseng	Dietary Supplement: Korean red ginseng; 5 capsules (300 mg/capsule) three times everyday for 12 weeks; Other Names: Korean Red Ginseng Powder Capsule, KGC1039012

Outcome Measures

Primary Outcome Measures

1. Change in the Pre- and Post-treatment Systolic Blood Pressure [baseline and 12 weeks]

Secondary Outcome Measures

1. Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) [baseline and 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei Univeristy College of Medicine, Gangnam Severance Hospital	Seoul		Korea, Republic of	135-720

Sponsors and Collaborators

• The Korean Society of Ginseng

Investigators

• Principal Investigator: Jae-Yong Shim, Ph.D., Yonsei University College of Medicine Gangnam severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jae-Yong Shim, Professor, The Korean Society of Ginseng
• ClinicalTrials.gov Identifier: NCT00976274
• Other Study ID Numbers: 3-2009-0015
• First Posted: Sep 14, 2009
• Last Update Posted: Feb 27, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Jae-Yong Shim, Professor, The Korean Society of Ginseng: Korean red ginseng; metabolic syndrome; blood pressure; arterial stiffness; inflammation; oxidative stress
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

Participant Flow

Arm/Group Title	Starch Capsule	Korea Red Ginseng
Arm/Group Description	5 capsules three times everyday for 12 weeks	5 capsules (300mg/capsule) three times everyday for 12 weeks
Period Title: Overall Study
STARTED	31	29
COMPLETED	24	21
NOT COMPLETED	7	8

Baseline Characteristics

Arm/Group Title	Starch Capsule	Korea Red Ginseng	Total
Arm/Group Description	5 capsules three times everyday for 12 weeks	5 capsules (300mg/capsule) three times everyday for 12 weeks	Total of all reporting groups
Overall Participants	31	29	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	29 93.5%	28 96.6%	57 95%
>=65 years	2 6.5%	1 3.4%	3 5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.2 (11.0)	43.1 (10.6)	44.7 (10.8)
Sex: Female, Male (Count of Participants)
Female	12 38.7%	9 31%	21 35%
Male	19 61.3%	20 69%	39 65%
Region of Enrollment (participants) [Number]
Korea, Republic of	31 100%	29 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Change in the Pre- and Post-treatment Systolic Blood Pressure
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Starch Capsule	Korea Red Ginseng
Arm/Group Description	5 capsules three times everyday for 12 weeks	5 capsules (300mg/capsule) three times everyday for 12 weeks
Measure Participants	24	21
Week 0	129.5 (10.7)	134.5 (12.5)
Week 12	122.6 (13.2)	127.5 (13.6)

2. Secondary Outcome

Title	Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Starch Capsule	Korea Red Ginseng
Arm/Group Description	5 capsules three times everyday for 12 weeks	5 capsules (300mg/capsule) three times everyday for 12 weeks
Measure Participants	24	21
0 week	83.3 (35.9)	78.8 (37.2)
12 week	83.4 (36.7)	76.3 (29.0)

Adverse Events

Arm/Group Title	Starch Capsule		Korea Red Ginseng
Arm/Group Description	5 capsules three times everyday for 12 weeks		5 capsules (300mg/capsule) three times everyday for 12 weeks
All Cause Mortality
	Starch Capsule		Korea Red Ginseng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Starch Capsule		Korea Red Ginseng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Starch Capsule		Korea Red Ginseng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.