HealthyNCT02428998
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
A study testing Korean Red Ginseng in people with Healthy and Diabetes, run by Korea Ginseng Corporation at 1 site in South Korea.
Trial summary
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Diabetes, Hypertension
- What is being tested?
- Korean Red Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Apr 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years or older
- agree to participate in this test, voluntarily signed by the parties to a written agreement
- In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
Who cannot join
- Pregnant and lactating mothers
- Patients with a history of hypersensitivity to contain ingredients that caused the test food
- patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
- Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
- autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
- patients with uncontrolled diabetes (for HbA1c 8.0% or more)
Show all 17Show fewer
- Sulphonylureas, diabetic patients being treated with Insulin
- , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
- uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
- patients with uncontrolled thyroid dysfunction
- patients with a dementia or psychiatric problems
- treated with systemic steroid screening visit within 1 weeks ago
- before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
- taking the medicine within 4 weeks before the screening visit
- taking the other investigational drugs or human test food application within four weeks before the screening visit
- taking health supplements other than vitamins and minerals within 2 weeks before randomization
- which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic Universtiy of Korea. Seoul St Mary's Hospital
Seoul, 137-701
About this study
Official title: Safety Evaluation for 24 Weeks Intake of Korean Red Ginseng in Adults: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Exploratory Trial
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.
- Conditions
- Healthy, Diabetes, Hypertension, Hyperlipidemia
- Being tested
- Korean Red Ginseng, Placebo
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng | Experimental | Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses Receives: Dietary Supplement: Korean Red Ginseng |
| Placebo | Placebo comparator | Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All adverse events occurring up to 24 weeks time after taking the Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Secondary outcomes (6)
Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product
Measured: up to 24 weeks to collect all focus point after taking the Investigational product
Cardiovascular adverse events that occurred after taking the Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Gastrointestinal adverse events that occurred after ingestion of Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Neuropsychiatric adverse events that occurred after ingestion of Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Grade 3 adverse events that occurred after ingestion of Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product
Measured: up to 24 weeks time after taking the Investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Ginseng Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungsoo Kim, M.D., Ph.D, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428998
- Sponsor's protocol ID
- KGC-S-01
- Status last verified
- Aug 2017
- First submitted
- 20 Apr 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation for 24 Weeks Intake of Korean Red Ginseng in Adults: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Exploratory Trial
- ClinicalTrials.gov ID
- NCT02428998
- Acronym / sponsor ID
- KGC-S-01
- Conditions
- Healthy, Diabetes, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Korea Ginseng CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng | Experimental | Dietary Supplement: Korean Red GinsengPatients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years or older
- agree to participate in this test, voluntarily signed by the parties to a written agreement
- In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
Key exclusion criteria (17 listed)
- Pregnant and lactating mothers
- Patients with a history of hypersensitivity to contain ingredients that caused the test food
- patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
- Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
- autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
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 Ginseng | Dietary supplement | Korean Red Ginseng |
| Placebo | Dietary supplement | Placebo |
Primary outcome
All adverse events occurring up to 24 weeks time after taking the Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
6 secondary outcomes
Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product
Time frame: up to 24 weeks to collect all focus point after taking the Investigational product
Cardiovascular adverse events that occurred after taking the Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
Gastrointestinal adverse events that occurred after ingestion of Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
Neuropsychiatric adverse events that occurred after ingestion of Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
Grade 3 adverse events that occurred after ingestion of Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product
Time frame: up to 24 weeks time after taking the Investigational product
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 11 Aug 2017.
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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.
Kyungsoo Kim, M.D., Ph.D principal investigator
The Catholic University of Korea
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 in people with Healthy and Diabetes, run by Korea Ginseng Corporation 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 3 inclusion and 17 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 11 Aug 2017. 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?
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?
All adverse events occurring up to 24 weeks time after taking the Investigational product (time frame: up to 24 weeks time after taking the Investigational product). 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 11 Aug 2017.