HyperlipidemiasNCT03828188
Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
A study testing Red Ginseng Concentrated Powder in people with Hyperlipidemias, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Red Ginseng Concentrated Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2018to 8 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-70 years with Triglyceride 120-200 mg/dL
Who cannot join
- Lipid lowering agent within past 6 months
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Persons with significant hypersensitivity reactions to ginseng and red ginseng
- Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
- Those who have received antipsychotic medication within 2 months before screening
- Those with a history of alcoholism or substance abuse
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- Those who participated in other clinical trials within 2 months before screening
- Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.
Read the detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)
- Conditions
- Hyperlipidemias
- Being tested
- Red Ginseng Concentrated Powder, Placebo
- Keywords
- Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Ginseng Concentrated PowderDietary supplement
Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
PlaceboDietary supplement
Placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.
* Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
* Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) Receives: Dietary Supplement: Red Ginseng Concentrated Powder; Dietary Supplement: Placebo |
| group B | Experimental | Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.
* Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
* Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) Receives: Dietary Supplement: Red Ginseng Concentrated Powder; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Fasting triglyceride
Changes of Fasting triglyceride was assessed before and after the intervention
Measured: 12 weeks
Secondary outcomes (4)
Changes of Lipid metabolism indices
Lipid metabolism indices were assessed before and after the intervention. The lipid metabolism index should be measured by collecting blood while keeping fasting for 12 hours or more. The inspection items are as follows.
- Total cholesterol, triglyceride, LDL-C, HDL-C, Non HDL-C, VLDL-C, free fatty acid, Apo A1, Apo B, hs-CRP
- Non HDL-C and VLDL-C are calculated by the calculation formula, and the first digit of the decimal point is indicated.
- Non HDL-C= Total cholesterol - HDL-C VLDL-C= Total cholesterol - (HDL-C + LDL-C)
Measured: 30 weeks
Changes of Arteriosclerosis indices
It is calculated by the calculation formula using the lipid metabolism indicator test item. Round off the third decimal place to the second decimal place. The items are as follows:
- Total cholesterol/HDL-C, LDL-C/HDL-C, triglycerid/HDL-C, (Total cholesterol - HDL-C)/HDL-C, Apo B/Apo A1
Measured: 30 weeks
Changes of Carnitine (Serum)
Carnitine (Serum)[μmol/L] was assessed before and after the intervention.
Measured: 30 weeks
Changes of lipoprotein lipase
lipoprotein lipase[ng/ml] was assessed before and after the intervention
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Mar 2018
- Primary completion11 May 2018
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828188
- Sponsor's protocol ID
- JAR-FHL-RG2
- Status last verified
- May 2020
- First submitted
- 30 Jan 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
- ClinicalTrials.gov ID
- NCT03828188
- Acronym / sponsor ID
- JAR-FHL-RG2
- Conditions
- Hyperlipidemias
- Keywords
- Red Ginseng Concentrated Powder, Hyperlipidemias, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.
Detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Dietary Supplement: Red Ginseng Concentrated Powder, Dietary Supplement: PlaceboRed Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks. * Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) * Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) |
| group B | Experimental | Dietary Supplement: Red Ginseng Concentrated Powder, Dietary Supplement: PlaceboPlacebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks. * Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) * Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-70 years with Triglyceride 120-200 mg/dL
Key exclusion criteria (13 listed)
- Lipid lowering agent within past 6 months
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Persons with significant hypersensitivity reactions to ginseng and red ginseng
- Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
- Those who have received antipsychotic medication within 2 months before screening
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 |
|---|---|---|
| Red Ginseng Concentrated PowderRed Ginseng Concentrated Powder(4.9 g/day) for 12 weeks. | Dietary supplement | group A, group B |
| PlaceboPlacebo for 12 weeks. | Dietary supplement | group A, group B |
Primary outcome
Changes of Fasting triglyceride
Time frame: 12 weeks
Changes of Fasting triglyceride was assessed before and after the intervention
4 secondary outcomes
Changes of Lipid metabolism indices
Time frame: 30 weeks
Changes of Arteriosclerosis indices
Time frame: 30 weeks
Changes of Carnitine (Serum)
Time frame: 30 weeks
Changes of lipoprotein lipase
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Ginseng Concentrated Powder in people with Hyperlipidemias, run by Chonbuk National University Hospital 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 1 inclusion and 13 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 8 May 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of Fasting triglyceride (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2020.