Red Ginseng Extract With Climacteric Symptoms
关键词
抽象
描述
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.
日期
| 最后验证: | 02/28/2019 |
| 首次提交: | 03/03/2019 |
| 提交的预估入学人数: | 03/04/2019 |
| 首次发布: | 03/06/2019 |
| 上次提交的更新: | 03/04/2019 |
| 最近更新发布: | 03/06/2019 |
| 实际学习开始日期: | 02/28/2019 |
| 预计主要完成日期: | 01/31/2020 |
| 预计完成日期: | 01/31/2020 |
状况或疾病
干预/治疗
Dietary Supplement: Korean Red Ginseng
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Changes in gut microbiota at 24 weeks vs baseline [24 weeks]
次要成果指标
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]
