HyperglycemiaNCT03775733
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
A study testing Hydrolysed Red Ginseng Extract in people with Hyperglycemia, 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 hydrolysed red ginseng extract on improvement of Hyperglycemia. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Hydrolysed Red Ginseng Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Sep 2018to 31 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-80 years with fasting glucose 100-140 mg/dL
Who cannot join
- Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
- Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
- Blood sugar improvement or healthy functional food within past 1 month
- Under antipsychotic medication therapy within past 2 months
- History of alcohol or substance abuse
Show all 13Show fewer
- Participation in any other clinical trials within past 2 months
- Laboratory test by show the following results
- aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dl
- Pregnancy or breast feeding
- If a woman of childbearing doesn't accept the implementation of appropriate contraception
- 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, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Soo-Wan Chae, MD., PhD, 82-63-259-3040, swchae@jbctc.org
About this study
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.
Read the detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
- Conditions
- Hyperglycemia
- Being tested
- Hydrolysed Red Ginseng Extract, Placebo
- Keywords
- Hydrolysed red ginseng extract, Glucose, Clinical Trial
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed Red Ginseng ExtractDietary supplement
Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
PlaceboDietary supplement
Placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysed red ginseng extract | Experimental | Hydrolysed red ginseng extract 2.4g/day for 12 weeks Receives: Dietary Supplement: Hydrolysed Red Ginseng Extract |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Measured: 12 weeks
Secondary outcomes (7)
Changes of blood insulin
Changes of blood insulin during OGTT were assessed before and after the intervention.
Measured: 12 weeks
Changes of area under the curve of Glucose and Insulin
Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.
Measured: 12 weeks
Changes of Homeostatic model assessment-insulin resistance
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.
Measured: 12 weeks
Changes of Homeostatic model assessment-beta-cell
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Measured: 12 weeks
Changes of HbA1c
Changes of HbA1c(%) were assessed before and after the intervention
Measured: 12 weeks
Changes of C-peptide
Changes of C-peptide(ng/ml) were assessed before and after the intervention.
Measured: 12 weeks
Changes of lipid profile
Changes of lipid profile were assessed before and after the intervention.
Measured: 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 Dec 2018
- Study start7 Sep 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
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
- NCT03775733
- Sponsor's protocol ID
- GH-HG-HR
- Status last verified
- May 2020
- First submitted
- 12 Dec 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
- ClinicalTrials.gov ID
- NCT03775733
- Acronym / sponsor ID
- GH-HG-HR
- Conditions
- Hyperglycemia
- Keywords
- Hydrolysed red ginseng extract, Glucose, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Dec 2018 (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 hydrolysed red ginseng extract on improvement of Hyperglycemia.
Detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolysed red ginseng extract | Experimental | Dietary Supplement: Hydrolysed Red Ginseng ExtractHydrolysed red ginseng extract 2.4g/day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-80 years with fasting glucose 100-140 mg/dL
Key exclusion criteria (13 listed)
- Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
- Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
- Blood sugar improvement or healthy functional food within past 1 month
- Under antipsychotic medication therapy within past 2 months
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 |
|---|---|---|
| Hydrolysed Red Ginseng ExtractHydrolysed Red Ginseng Extract 2.4g/day for 12 weeks. | Dietary supplement | Hydrolysed red ginseng extract |
| PlaceboPlacebo for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes of blood glucose
Time frame: 12 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
7 secondary outcomes
Changes of blood insulin
Time frame: 12 weeks
Changes of area under the curve of Glucose and Insulin
Time frame: 12 weeks
Changes of Homeostatic model assessment-insulin resistance
Time frame: 12 weeks
Changes of Homeostatic model assessment-beta-cell
Time frame: 12 weeks
Changes of HbA1c
Time frame: 12 weeks
Changes of C-peptide
Time frame: 12 weeks
Changes of lipid profile
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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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.
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, South 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 Hydrolysed Red Ginseng Extract in people with Hyperglycemia, 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: status not confirmed, 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose (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.