Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Liver Enzymes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis
排除标准
- •viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
研究组 & 干预措施
Korea Red Ginseng (KRG)
KRG capsule (3,000 mg/day) for 3 weeks
干预措施: KRG (Korea Red ginseng) (Drug)
Placebo (for KRG)
placebo (for KRG) for 3 weeks
干预措施: Placebo (for KRG) (Drug)
结局指标
主要结局
Liver Enzymes
时间窗: 3 weeks of KRG
aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase
次要结局
- Pro-inflammatory Cytokine(3 weeks of KRG)
- Fatigue as Measured by KRUPP's Fatigue Severity Scale(3 weeks of KRG)
- Adiponectin(3 weeks of KRG)
研究者
Ki Tae Suk
doctor, assistant professor
Chuncheon Sacred Heart Hospital