Efficacy and Safety of Fermented Ginseng Powder on Liver Function
キーワード
概要
説明
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.
日付
| 最終確認済み: | 01/31/2018 |
| 最初に提出された: | 03/22/2017 |
| 提出された推定登録数: | 08/20/2017 |
| 最初の投稿: | 08/23/2017 |
| 最終更新が送信されました: | 01/31/2018 |
| 最終更新日: | 02/04/2018 |
| 実際の研究開始日: | 06/30/2016 |
| 一次完了予定日: | 10/31/2016 |
| 研究完了予定日: | 07/31/2017 |
状態または病気
介入/治療
Dietary Supplement: fermented ginseng powder
Dietary Supplement: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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. |
適格基準
| 研究の対象となる年齢 | 19 Years に 19 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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. |
結果
主な結果の測定
1. Changes of ALT(Alanine Transaminase) [Baseline and 12 weeks]
二次的な結果の測定
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]
