Red Ginseng Extract With Climacteric Symptoms
キーワード
概要
説明
A screening test is conducted for those who have agreed in writing with a detailed explanation of the purpose of this study and research methods, and then a person who meets the selection / exclusion criteria is selected.
Give a registration number to the person selected as the subject through the screening, and take one pack of the product (3g) once a day for 24 weeks in a human body application test.
Prior to taking the registration number (1Day), the efficacy evaluation items and the safety evaluation items are carried out. At the 24 weeks after the starting point of taking the product of human application test, the evaluation items are conducted through outpatient visits.
日付
| 最終確認済み: | 02/28/2019 |
| 最初に提出された: | 03/03/2019 |
| 提出された推定登録数: | 03/04/2019 |
| 最初の投稿: | 03/06/2019 |
| 最終更新が送信されました: | 03/04/2019 |
| 最終更新日: | 03/06/2019 |
| 実際の研究開始日: | 02/28/2019 |
| 一次完了予定日: | 01/31/2020 |
| 研究完了予定日: | 01/31/2020 |
状態または病気
介入/治療
Dietary Supplement: Korean Red Ginseng
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Korean Red Ginseng Product: Red ginseng Everytime 1 pack(3g/day) | Dietary Supplement: Korean Red Ginseng Take one pack of the product (3g) once a day for 24 weeks |
適格基準
| 研究の対象となる年齢 | 40 Years に 40 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: 1. Age of 40~75 men and women 2. Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness 3. Those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test Exclusion Criteria: 1. Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.) 2. Patients with a history of antibiotic treatment for more than 1 month within the last 6 months 3. Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) 4. Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year 5. Those who are currently participating in other clinical studies or human trials, or participating in clinical trials or human application tests within the past month |
結果
主な結果の測定
1. Changes in gut microbiota at 24 weeks vs baseline [24 weeks]
二次的な結果の測定
1. Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline [24 weeks]
2. Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline [24 weeks]
3. Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline [24 weeks]
4. Changes in Heart rate variability at 24 weeks vs baseline [24 weeks]
