A 24-week, Single-center, Open-label Study to Evaluate Gut Microbiota, Immunity, Oxidative Stress and Autonomic Nerve System of Red Ginseng Extract in Subjects With Climacteric Symptoms.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 53
- 主要终点
- Changes in gut microbiota at 24 weeks vs baseline
研究概览
简要总结
The purpose of this study is to investigate the positive effects of red ginseng extract on intestinal bacterial changes and immunity, free radicals, antioxidant capacity, and autonomic nervous system changes in age of 40~75 men and women with climacteric symptoms for 24 weeks.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 40~75 men and women
- •Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness
- •Those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test
排除标准
- •Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
- •Patients with a history of antibiotic treatment for more than 1 month within the last 6 months
- •Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery)
- •Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year
- •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
结局指标
主要结局
Changes in gut microbiota at 24 weeks vs baseline
时间窗: 24 weeks
次要结局
- Changes in Total Oxidant Status(TOS in µmol/L) at 24 weeks vs baseline(24 weeks)
- Changes in Heart rate variability at 24 weeks vs baseline(24 weeks)
- Changes in Natural Killer(NK) cell activity at 24 weeks vs baseline(24 weeks)
- Changes in Total Antioxidant Status(TAS in mmol/L) at 24 weeks vs baseline(24 weeks)