A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Fermented Ginseng Powder on Liver Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes of ALT(Alanine Transaminase)
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.
详细描述
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation index, and Multidimensional Fatigue Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-70 years with ALT 35-105 IU/L
排除标准
- •Under antipsychotic drugs therapy within past 2 months
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test by show the following results
- •Serum Creatinine > 2.0 mg/dl
- •Pregnancy or breast feeding etc.
研究组 & 干预措施
Placebo
Placebo for 12 weeks.
干预措施: Placebo (Dietary Supplement)
fermented ginseng powder
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
干预措施: fermented ginseng powder (Dietary Supplement)
结局指标
主要结局
Changes of ALT(Alanine Transaminase)
时间窗: Baseline and 12 weeks
Changes of ALT were assessed before and after the intervention
次要结局
- Changes of total antioxidant capacity(Baseline and 12 weeks)
- Changes of Liver function index(Baseline and 12 weeks)
- Changes of fatty liver grade(Baseline and 12 weeks)
- Changes of imflammation index(Baseline and 12 weeks)
- Changes of Multidimensional Fatigue Scale(Baseline and 12 weeks)
- Changes of lipid metabolism index(Baseline and 12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital