Metabolic SyndromeNCT00976274
Korean Red Ginseng and Metabolic Syndrome
A study testing Korean red ginseng and starch in people with Metabolic Syndrome, run by The Korean Society of Ginseng at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Korean red ginseng and starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Univeristy College of Medicine, Gangnam Severance Hospital
Seoul, 135-720
About this study
Official title: Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome
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.
Read the 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
- Conditions
- Metabolic Syndrome
- Being tested
- Korean red ginseng, starch
- Keywords
- Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean red ginsengDietary supplement
Also called Korean Red Ginseng Powder Capsule, KGC1039012
5 capsules (300 mg/capsule) three times everyday for 12 weeks
starchDietary supplement
Also called KGC1039015
5 capsules three times everyday for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| starch capsule | Placebo comparator | Not described Receives: Dietary Supplement: starch |
| Korea red ginseng | Experimental | Not described Receives: Dietary Supplement: Korean red ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Pre- and Post-treatment Systolic Blood Pressure
Measured: baseline and 12 weeks
Secondary outcomes (1)
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Ginseng
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Yong Shim, The Korean Society of Ginseng
- Investigators
- Jae-Yong Shim, Ph.D., Principal investigator, Yonsei University College of Medicine Gangnam severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976274
- Sponsor's protocol ID
- 3-2009-0015
- Status last verified
- Feb 2012
- First submitted
- 11 Sep 2009
- Last updated
- 27 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22916320
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00976274
- Acronym / sponsor ID
- 3-2009-0015
- Conditions
- Metabolic Syndrome
- Keywords
- Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Korean Society of GinsengUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| starch capsule | Placebo comparator | Dietary Supplement: starch |
| Korea red ginseng | Experimental | Dietary Supplement: Korean red ginseng |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean red ginsengAlso: Korean Red Ginseng Powder Capsule, KGC10390125 capsules (300 mg/capsule) three times everyday for 12 weeks | Dietary supplement | Korea red ginseng |
| starchAlso: KGC10390155 capsules three times everyday for 12 weeks | Dietary supplement | starch capsule |
Primary outcome
Change in the Pre- and Post-treatment Systolic Blood Pressure
Time frame: baseline and 12 weeks
1 secondary outcome
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22916320Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Yong Shim, Ph.D. principal investigator
Yonsei University College of Medicine Gangnam severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean red ginseng and starch in people with Metabolic Syndrome, run by The Korean Society of Ginseng at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Pre- and Post-treatment Systolic Blood Pressure (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.