Skip to main content
OpenTrials
Completed

NCT Number: NCT02331589

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fatigue Chronic Disease Digestive System Diseases Disease Attributes Fatty Liver Hepatitis Hepatitis, Chronic Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRG (Korea Red ginseng)

Drug

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

Other names: Korea Red ginseng capsule (3,000 mg/day)

Placebo (for KRG)

Drug

Placebos with same shape and size were manufactured and at Korea Ginseng Corporation

Other names: Placebo

Primary outcomes

  1. Liver Enzymes

    Time frame: 3 weeks of KRG

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

Secondary outcomes

  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:

    • 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

  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

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2015
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.