Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Concentration of Gamma-Glutamyl Transpeptidase
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.
详细描述
Previous studies have indicated that Fermented Protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. The Investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 4,000 mg of Fermented Protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit
排除标准
- •Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
- •Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- •History of viral hepatitis or cancer
- •Uncontrolled hypertension
- •History of serious cardiac disease such as angina or myocardial infarction
- •History of gastrectomy
- •History of medication for psychiatric disease
- •Administration of oriental medicine including herbs within the past 4 weeks
结局指标
主要结局
Concentration of Gamma-Glutamyl Transpeptidase
时间窗: 8 weeks
Gamma-Glutamyl Transpeptidase
次要结局
- Concentration of Alanine aminotransferase(8 weeks)
- Concentration of Aspartate aminotransferase(8 weeks)
- Fatigue Severity Scale(8 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital