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

February 8, 2015 updated by: Ki Tae Suk, Chuncheon Sacred Heart Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 8, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFEKRG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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