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Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
KRG (Korea Red ginseng)
Placebo (for KRG)
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

Exclusion Criteria:

  • viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Korea Red Ginseng (KRG)

    Placebo (for KRG)

    Arm Description

    KRG capsule (3,000 mg/day) for 3 weeks

    placebo (for KRG) for 3 weeks

    Outcomes

    Primary Outcome Measures

    Liver Enzymes
    aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase

    Secondary Outcome Measures

    Fatigue as Measured by KRUPP's Fatigue Severity Scale
    KRUPP's fatigue severity scale. The survey has nine questions as following: my motivation is lower, when I am fatigued exercise brings on my fatigue I am easily fatigued fatigue interferes with my physical functioning fatigue causes frequent problems for me my fatigue prevents sustained physical functioning fatigue interferes with carrying out certain duties and responsibilities fatigue is among my 3 most disabling symptoms fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). Scores range from 9 to 63, with higher scores indicating higher fatigue
    Pro-inflammatory Cytokine
    tumor necrosis factor-alpha, interleukin-6
    Adiponectin
    enzyme-linked immunosorbent assay

    Full Information

    First Posted
    December 31, 2014
    Last Updated
    February 8, 2015
    Sponsor
    Chuncheon Sacred Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02331589
    Brief Title
    Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
    Official Title
    Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue. Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
    Detailed Description
    Fatigue Severity Scale We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue
    Keywords
    Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Korea Red Ginseng (KRG)
    Arm Type
    Active Comparator
    Arm Description
    KRG capsule (3,000 mg/day) for 3 weeks
    Arm Title
    Placebo (for KRG)
    Arm Type
    Placebo Comparator
    Arm Description
    placebo (for KRG) for 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    KRG (Korea Red ginseng)
    Other Intervention Name(s)
    Korea Red ginseng capsule (3,000 mg/day)
    Intervention Description
    3 weeks of KRG capsule (3,000 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (for KRG)
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
    Primary Outcome Measure Information:
    Title
    Liver Enzymes
    Description
    aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase
    Time Frame
    3 weeks of KRG
    Secondary Outcome Measure Information:
    Title
    Fatigue as Measured by KRUPP's Fatigue Severity Scale
    Description
    KRUPP's fatigue severity scale. The survey has nine questions as following: my motivation is lower, when I am fatigued exercise brings on my fatigue I am easily fatigued fatigue interferes with my physical functioning fatigue causes frequent problems for me my fatigue prevents sustained physical functioning fatigue interferes with carrying out certain duties and responsibilities fatigue is among my 3 most disabling symptoms fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). Scores range from 9 to 63, with higher scores indicating higher fatigue
    Time Frame
    3 weeks of KRG
    Title
    Pro-inflammatory Cytokine
    Description
    tumor necrosis factor-alpha, interleukin-6
    Time Frame
    3 weeks of KRG
    Title
    Adiponectin
    Description
    enzyme-linked immunosorbent assay
    Time Frame
    3 weeks of KRG

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis Exclusion Criteria: viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer

    12. IPD Sharing Statement

    Learn more about this trial

    Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis

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