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

NCT ID: NCT02331589

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Korea Red Ginseng (KRG)

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

Group Type: ACTIVE_COMPARATOR

KRG (Korea Red ginseng)

Intervention Type: DRUG

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

Placebo (for KRG)

placebo (for KRG) for 3 weeks

Group Type: PLACEBO_COMPARATOR

Placebo (for KRG)

Intervention Type: DRUG

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

Interventions

KRG (Korea Red ginseng)

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

Intervention Type: DRUG

Placebo (for KRG)

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

Intervention Type: DRUG

Other Intervention Names

Korea Red ginseng capsule (3,000 mg/day); Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ki Tae Suk

doctor, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AFEKRG

Identifier Type: -

Identifier Source: org_study_id