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出境医 / 临床实验 / Effects of Red Ginseng on Liver Function

Effects of Red Ginseng on Liver Function

Study Description
Brief Summary:
Korea Red Ginseng (KRG) has effect on liver function

Condition or disease Intervention/treatment Phase
Liver Dysfunction Dietary Supplement: Red ginseng Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Ginseng trial
compare experimental group to controlled group
 Dietary Supplement: Red ginseng
Red ginseng tablet 120g
Other Name: Red ginseng tablet
Outcome Measures
Primary Outcome Measures :
  1. Liver enzyme [ Time Frame: 1year ]
    Decrease liver enzyme level


Eligibility Criteria
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Ages Eligible for Study:   37 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Korea, Republic of
ChuncheonSHH
Chuncheon, Kangwon, Korea, Republic of
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Study Chair: Ki Tae Suk, PhD.Md. Chuncheon Sacred Heart Hospital
Principal Investigator: Jun Seok, MD. Chuncheon Sacred Heart Hospital
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019) 		Liver enzyme [ Time Frame: 1year ]
Decrease liver enzyme level
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Red Ginseng on Liver Function
Official Title  ICMJE Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Dysfunction
Intervention  ICMJE Dietary Supplement: Red ginseng
Red ginseng tablet 120g
Other Name: Red ginseng tablet
Study Arms  ICMJE Experimental: Ginseng trial
compare experimental group to controlled group
Intervention: Dietary Supplement: Red ginseng
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2019) 		94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 37 Years to 63 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945123
Other Study ID Numbers  ICMJE RIVER
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not yet
Responsible Party Ki Tae Suk, Chuncheon Sacred Heart Hospital
Study Sponsor  ICMJE Chuncheon Sacred Heart Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ki Tae Suk, PhD.Md. Chuncheon Sacred Heart Hospital
Principal Investigator: Jun Seok, MD. Chuncheon Sacred Heart Hospital
PRS Account Chuncheon Sacred Heart Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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