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

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

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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