Efficacy and Safety of Fermented Ginseng Powder on Liver Function
关键词
抽象
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.
日期
| 最后验证: | 01/31/2018 |
| 首次提交: | 03/22/2017 |
| 提交的预估入学人数: | 08/20/2017 |
| 首次发布: | 08/23/2017 |
| 上次提交的更新: | 01/31/2018 |
| 最近更新发布: | 02/04/2018 |
| 实际学习开始日期: | 06/30/2016 |
| 预计主要完成日期: | 10/31/2016 |
| 预计完成日期: | 07/31/2017 |
状况或疾病
干预/治疗
Dietary Supplement: fermented ginseng powder
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: fermented ginseng powder tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks. | Dietary Supplement: fermented ginseng powder tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks. |
| Placebo Comparator: Placebo Placebo for 12 weeks. | Dietary Supplement: Placebo Placebo for 12 weeks. |
资格标准
| 有资格学习的年龄 | 19 Years 至 19 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age 19-70 years with ALT 35-105 IU/L Exclusion Criteria: - 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. |
结果
主要结果指标
1. Changes of ALT(Alanine Transaminase) [Baseline and 12 weeks]
次要成果指标
1. Changes of Liver function index [Baseline and 12 weeks]
2. Changes of fatty liver grade [Baseline and 12 weeks]
3. Changes of lipid metabolism index [Baseline and 12 weeks]
4. Changes of total antioxidant capacity [Baseline and 12 weeks]
5. Changes of imflammation index [Baseline and 12 weeks]
6. Changes of Multidimensional Fatigue Scale [Baseline and 12 weeks]
