Fatigue Clinical Trial
Official title:
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Verified date | December 2014 |
Source | Chuncheon Sacred Heart Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chuncheon Sacred Heart Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver Enzymes | aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase | 3 weeks of KRG | Yes |
Secondary | 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 | Yes |
Secondary | Pro-inflammatory Cytokine | tumor necrosis factor-alpha, interleukin-6 | 3 weeks of KRG | Yes |
Secondary | Adiponectin | enzyme-linked immunosorbent assay | 3 weeks of KRG | Yes |
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