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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03775733
Other study ID # GH-HG-HR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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