- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
3 weeks of KRG capsule (3,000 mg/day)
Other Names:
|
Placebo Comparator: Placebo (for KRG)
placebo (for KRG) for 3 weeks
|
Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Other Names:
|
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:
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFEKRG
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