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Effects of Red Ginseng on Liver Function

Primary Purpose

Liver Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Red ginseng
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Dysfunction focused on measuring ginseng, Liver

Eligibility Criteria

37 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ChuncheonSHH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ginseng trial

Arm Description

compare experimental group to controlled group

Outcomes

Primary Outcome Measures

Liver enzyme
Decrease liver enzyme level

Secondary Outcome Measures

Full Information

First Posted
May 3, 2019
Last Updated
May 7, 2019
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03945123
Brief Title
Effects of Red Ginseng on Liver Function
Official Title
Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction
Keywords
ginseng, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginseng trial
Arm Type
Experimental
Arm Description
compare experimental group to controlled group
Intervention Type
Dietary Supplement
Intervention Name(s)
Red ginseng
Other Intervention Name(s)
Red ginseng tablet
Intervention Description
Red ginseng tablet 120g
Primary Outcome Measure Information:
Title
Liver enzyme
Description
Decrease liver enzyme level
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Suk, PhD.Md.
Organizational Affiliation
Chuncheon Sacred Heart Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jun Seok, MD.
Organizational Affiliation
Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChuncheonSHH
City
Chuncheon
State/Province
Kangwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not yet
Citations:
PubMed Identifier
33841012
Citation
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.
Results Reference
derived

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Effects of Red Ginseng on Liver Function

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