Trial Outcomes & Findings for Korean Red Ginseng and Metabolic Syndrome (NCT NCT00976274)

NCT ID: NCT00976274

Last Updated: 2012-02-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2012-02-27

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Starch Capsule 5 capsules three times everyday for 12 weeks	Korea Red Ginseng 5 capsules (300mg/capsule) three times everyday for 12 weeks
Overall Study Lost to Follow-up	5	5
Overall Study Withdrawal by Subject	1	1
Overall Study Physician Decision	1	2

Baseline Characteristics

Korean Red Ginseng and Metabolic Syndrome

Baseline characteristics by cohort

Measure	Starch Capsule n=31 Participants 5 capsules three times everyday for 12 weeks	Korea Red Ginseng n=29 Participants 5 capsules (300mg/capsule) three times everyday for 12 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	46.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	43.1 years STANDARD_DEVIATION 10.6 • n=7 Participants	44.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Korea, Republic of	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Starch Capsule n=24 Participants 5 capsules three times everyday for 12 weeks	Korea Red Ginseng n=21 Participants 5 capsules (300mg/capsule) three times everyday for 12 weeks
Change in the Pre- and Post-treatment Systolic Blood Pressure Week 0	129.5 mm Hg Standard Deviation 10.7	134.5 mm Hg Standard Deviation 12.5
Change in the Pre- and Post-treatment Systolic Blood Pressure Week 12	122.6 mm Hg Standard Deviation 13.2	127.5 mm Hg Standard Deviation 13.6

SECONDARY outcome

Timeframe: baseline and 12 weeks

Outcome measures

Measure	Starch Capsule n=24 Participants 5 capsules three times everyday for 12 weeks	Korea Red Ginseng n=21 Participants 5 capsules (300mg/capsule) three times everyday for 12 weeks
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) 0 week	83.3 uIU/mL Standard Deviation 35.9	78.8 uIU/mL Standard Deviation 37.2
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) 12 week	83.4 uIU/mL Standard Deviation 36.7	76.3 uIU/mL Standard Deviation 29.0

Adverse Events

Starch Capsule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Korea Red Ginseng

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jae-Yong Shim

Department of Family Medicine, Yonsei University College of Medicine

Phone: (+82) 2-2019-3480

Email: hope@yuhs.ac

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place