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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatigue

Intervention / Treatment
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* Drug: KRG (Korea Red ginseng)
* Drug: Placebo (for KRG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Korea Red Ginseng (KRG)<br>KRG capsule (3,000 mg/day) for 3 weeks | Drug: KRG (Korea Red ginseng)<br>* 3 weeks of KRG capsule (3,000 mg/day)<br>* Other names: Korea Red ginseng capsule (3,000 mg/day);|
| Placebo Comparator: Placebo (for KRG)<br>placebo (for KRG) for 3 weeks | Drug: Placebo (for KRG)<br>* Placebos with same shape and size were manufactured and at Korea Ginseng Corporation<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Enzymes | aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase | 3 weeks of KRG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 weeks of KRG | 
| Pro-inflammatory Cytokine | tumor necrosis factor-alpha, interleukin-6 | 3 weeks of KRG | 
| Adiponectin | enzyme-linked immunosorbent assay | 3 weeks of KRG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Panax ginseng, Chronic hepatitis, Non-alcoholic Fatty Liver Disease, Adiponectin