- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775733
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
May 7, 2020 updated by: Soo-Wan Chae, Chonbuk National University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
- Recruiting
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 19-80 years with fasting glucose 100-140 mg/dL
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo for 12 weeks
|
Placebo for 12 weeks.
|
Experimental: Hydrolysed red ginseng extract
Hydrolysed red ginseng extract 2.4g/day for 12 weeks
|
Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of blood glucose
Time Frame: 12 weeks
|
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of blood insulin
Time Frame: 12 weeks
|
Changes of blood insulin during OGTT were assessed before and after the intervention.
|
12 weeks
|
Changes of area under the curve of Glucose and Insulin
Time Frame: 12 weeks
|
Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.
|
12 weeks
|
Changes of Homeostatic model assessment-insulin resistance
Time Frame: 12 weeks
|
Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.
|
12 weeks
|
Changes of Homeostatic model assessment-beta-cell
Time Frame: 12 weeks
|
Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
|
12 weeks
|
Changes of HbA1c
Time Frame: 12 weeks
|
Changes of HbA1c(%) were assessed before and after the intervention
|
12 weeks
|
Changes of C-peptide
Time Frame: 12 weeks
|
Changes of C-peptide(ng/ml) were assessed before and after the intervention.
|
12 weeks
|
Changes of lipid profile
Time Frame: 12 weeks
|
Changes of lipid profile were assessed before and after the intervention.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2018
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 12, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 7, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH-HG-HR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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