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

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ClinicalTrials.gov Identifier: NCT02331589
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital

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.


Condition or disease Intervention/treatment Phase
Fatigue Drug: KRG (Korea Red ginseng) Drug: Placebo (for KRG) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Study Start Date : August 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Active Comparator: Korea Red Ginseng (KRG)
KRG capsule (3,000 mg/day) for 3 weeks
Drug: KRG (Korea Red ginseng)
3 weeks of KRG capsule (3,000 mg/day)
Other Name: Korea Red ginseng capsule (3,000 mg/day)

Placebo Comparator: Placebo (for KRG)
placebo (for KRG) for 3 weeks
Drug: Placebo (for KRG)
Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Other Name: Placebo




Primary Outcome Measures :
  1. Liver Enzymes [ Time Frame: 3 weeks of KRG ]
    aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase


Secondary Outcome Measures :
  1. Fatigue as Measured by KRUPP's Fatigue Severity Scale [ Time Frame: 3 weeks of KRG ]

    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).

    Scores range from 9 to 63, with higher scores indicating higher fatigue


  2. Pro-inflammatory Cytokine [ Time Frame: 3 weeks of KRG ]
    tumor necrosis factor-alpha, interleukin-6

  3. Adiponectin [ Time Frame: 3 weeks of KRG ]
    enzyme-linked immunosorbent assay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02331589    
Other Study ID Numbers: AFEKRG
First Posted: January 6, 2015    Key Record Dates
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015
Last Verified: December 2014
Keywords provided by Ki Tae Suk, Chuncheon Sacred Heart Hospital:
Fatigue
Panax ginseng
Chronic hepatitis
Non-alcoholic Fatty Liver Disease
Adiponectin
Additional relevant MeSH terms:
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Hepatitis
Fatigue
Liver Diseases
Digestive System Diseases
Signs and Symptoms