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Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

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ClinicalTrials.gov Identifier: NCT03775733
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Brief Summary:
This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

Condition or disease Intervention/treatment Phase
Hyperglycemia Dietary Supplement: Hydrolysed Red Ginseng Extract Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Hydrolysed red ginseng extract
Hydrolysed red ginseng extract 2.4g/day for 12 weeks
Dietary Supplement: Hydrolysed Red Ginseng Extract
Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.

Placebo Comparator: Placebo
Placebo for 12 weeks
Dietary Supplement: Placebo
Placebo for 12 weeks.




Primary Outcome Measures :
  1. Changes of blood glucose [ Time Frame: 12 weeks ]
    Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.


Secondary Outcome Measures :
  1. Changes of blood insulin [ Time Frame: 12 weeks ]
    Changes of blood insulin during OGTT were assessed before and after the intervention.

  2. 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.

  3. 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.

  4. 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

  5. Changes of HbA1c [ Time Frame: 12 weeks ]
    Changes of HbA1c(%) were assessed before and after the intervention

  6. Changes of C-peptide [ Time Frame: 12 weeks ]
    Changes of C-peptide(ng/ml) were assessed before and after the intervention.

  7. Changes of lipid profile [ Time Frame: 12 weeks ]
    Changes of lipid profile were assessed before and after the intervention.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775733


Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Soo-Wan Chae, MD., PhD    82-63-259-3040    swchae@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital

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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03775733     History of Changes
Other Study ID Numbers: GH-HG-HR
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Hydrolysed red ginseng extract
Glucose
Clinical Trial

Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases