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

Phase 4

Completed

• Conditions: Fatigue
• Interventions: Drug: KRG (Korea Red ginseng); Drug: Placebo (for KRG)

• Registration Number: NCT02331589
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-12
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Results First Submitted: 2015-01-07
• Results First Submitted QC: 2015-02-08
• Last Update Submitted: 2015-02-08
• Results First Posted: 2015-02-10
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korea Red Ginseng (KRG)	KRG (Korea Red ginseng)	KRG capsule (3,000 mg/day) for 3 weeks
Placebo (for KRG)	Placebo (for KRG)	placebo (for KRG) for 3 weeks

Primary Outcome Measures

Name	Time	Method
Liver Enzymes	3 weeks of KRG	aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase

Secondary Outcome Measures

Name	Time	Method
Pro-inflammatory Cytokine	3 weeks of KRG	tumor necrosis factor-alpha, interleukin-6
Fatigue as Measured by KRUPP's Fatigue Severity Scale	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
Adiponectin	3 weeks of KRG	enzyme-linked immunosorbent assay