Efficacy and Safety of Hydrolysed Red Ginseng Extract on... | NCT03775733

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

NCT03775733

Sponsor

Chonbuk National University Hospital

Status

Unknown status

Last Update Posted

May 8, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

Hydrolysed Red Ginseng Extract
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2018Actual

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Dec 12, 2018

First Submission Date that Met QC Criteria

Dec 12, 2018

First Posted Date

Dec 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2020

Last Update Posted Date

May 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrolysed red ginseng extract	Experimental	Hydrolysed red ginseng extract 2.4g/day for 12 weeks	Dietary Supplement: Hydrolysed Red Ginseng Extract
Placebo	Placebo Comparator	Placebo for 12 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrolysed Red Ginseng Extract	Dietary Supplement	Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.	Hydrolysed red ginseng extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of blood glucose	Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes of blood insulin	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	Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases