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

Hyperglycemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03775733
• Other study ID #: GH-HG-HR
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Dietary Supplement:
• Hydrolysed Red Ginseng Extract
Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
• Placebo
Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of blood glucose	Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.	12 weeks
Secondary	Changes of blood insulin	Changes of blood insulin during OGTT were assessed before and after the intervention.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	Changes of HbA1c	Changes of HbA1c(%) were assessed before and after the intervention	12 weeks
Secondary	Changes of C-peptide	Changes of C-peptide(ng/ml) were assessed before and after the intervention.	12 weeks
Secondary	Changes of lipid profile	Changes of lipid profile were assessed before and after the intervention.	12 weeks