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

Chuncheon Sacred Heart Hospital

Status and phase: Completed; Phase 4

Conditions: Fatigue

Treatments: Drug: Placebo (for KRG); Drug: KRG (Korea Red ginseng)

Study type: Interventional

Funder types: Other

Identifiers

NCT02331589

AFEKRG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups, including a placebo group

Korea Red Ginseng (KRG)

Active Comparator group

Description:

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

Treatment:

Drug: KRG (Korea Red ginseng)

Placebo (for KRG)

Placebo Comparator group

Description:

placebo (for KRG) for 3 weeks

Treatment:

Drug: Placebo (for KRG)