Effects of Red Ginseng on Liver Function | NCT03945123

Studies
Effects of Red Ginseng on Liver Function

NCT03945123

Sponsor

Chuncheon Sacred Heart Hospital

Status

Completed

Last Update Posted

May 10, 2019Actual

Enrollment

94Actual

Phase

Not Applicable

Conditions

Liver Dysfunction

Interventions

Red ginseng

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 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 3, 2019

First Submission Date that Met QC Criteria

May 7, 2019

First Posted Date

May 10, 2019Actual

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, 2019

Last Update Posted Date

May 10, 2019Actual

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

Korea Red Ginseng (KRG) has effect on liver function

Detailed Description

Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH

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

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ginseng trial	Experimental	compare experimental group to controlled group	Dietary Supplement: Red ginseng

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Red ginseng	Dietary Supplement	Red ginseng tablet 120g	Ginseng trial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liver enzyme	Decrease liver enzyme level	1year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AST or ALT level > 50 IU/L

Exclusion Criteria:

Viral hepatitis
Alcoholic hepatitis
Autoimmune hepatitis
Pancreatitis
Hemochromatosis
Wilson's disease
Drug induced liver injury
Cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

37 Years

Maximum Age

63 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ki Tae Suk, PhD.Md.	Chuncheon Sacred Heart Hospital	Study Chair
Jun Seok, MD.	Chuncheon Sacred Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ChuncheonSHH		Chuncheon	Gangwon-do		South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33841012	Derived	Hong JT, Lee MJ, Yoon SJ, Shin SP, Bang CS, Baik GH, Kim DJ, Youn GS, Shin MJ, Ham YL, Suk KT, Kim BS. Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function. J Ginseng Res. 2021 Mar;45(2):316-324. doi: 10.1016/j.jgr.2020.07.004. Epub 2020 Jul 16.