NCT05632341已完成不适用
GCWB1176 8 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Immune Function
Green Cross Wellbeing2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change amoust of NK Cell Activity
研究概览
简要总结
This human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of screening, 19 or 75 years
- •A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μl
- •Those who are more than one of the following standards
- •Those who had more than twice within one year of visiting 1 year.
- •{Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.
- •Those who have stomatitis more than twice within 1 year of visit
- •Those who had Herpes Zoster infection within 1 year of visit
- •Those with a stress awareness scale (PSS) 16 or more
- •A person who agrees to participate in this human application test before the start of the human test and writes a written consent form
排除标准
- •Those who are currently treating drugs due to underlying disease, etc.
- •Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
- •Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
- •Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
- •Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
- •A disease that can affect immune responses such as adult -like and rhinitis
- •AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
- •Those who are 1.5 times more than the normal upper limit of Creatinine
- •Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.
- •Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting
- •A person who has administered or consumed lactic acid bacteria products (4 or more times a week) within 2 weeks of visiting within 2 weeks of visit.
- •Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •Those who are pregnant or have a planning plan for lactation or this human application period
- •Those who have participated in other interventional clinical trials (including human application test) within 8 weeks of visit, or plan to participate in other interventional clinical trials (including human application tests) after the beginning of this human application test
- •Those who are sensitive or allergic to food ingredients for this human application
- •Those who have a BMI (body mass index) of 30 kg/m2 or more
- •A person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week)
- •Those who judge that the test person is inadequate for other reasons
研究组 & 干预措施
GCWB1176
Experimental
1 capsule once a day
干预措施: Lactococcus lactis (Dietary Supplement)
Placebo
Active Comparator
1 capsule once a day
干预措施: maltodextrin (Other)
结局指标
主要结局
Change amoust of NK Cell Activity
时间窗: week 0, 4 and 8
The comparison of the military comparison for the change before and after the intake of NK CELL Activity is analyzed using the PAIRED T-TEST, and the degree of change between the test group and the control at at each point is Two Sample T-Test or Wilcoxon Rank Sum Test It is conducted to evaluate whether there is a statistically significant difference.
次要结局
- Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)(week -2, 0, 4 and 8)
- Change amoust of WBC Count analysis(week -2, 0, 4 and 8)
- Change amoust of FSS Count analysis(week -2, 0, 4 and 8)
- Change amoust of upper respiratory infection analysis(week -2, 0, 4 and 8)
研究者
研究点 (2)
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