NCT05544942已完成不适用
GCWB1001 12 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Respiratory Health Health
Green Cross Wellbeing4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月23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
- 120
- 试验地点
- 4
- 主要终点
- Change amoust of BCSS
研究概览
简要总结
This human application test was designed to evaluate the effectiveness and safety of the losing suction tendon, compared to the control food when the GCWB1001 was consistent with the symptoms of the respiratory symptoms of mildness.
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
- 20 Years 至 69 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 70 years
- •Those who have two or more symptoms of cough, sputum, lake striking or chest stuffy for more than one month, and BCSS at 3 or more
- •Those with FEV 1 /FVC 70 or higher
- •Those who agreed to participation in this human application test before the beginning of the human test and signed in the Informed Consent Form
排除标准
- •Severe cardiovascular, immune system, gastrointestinal and biliary meters, kidney and urinary systems, Those who are currently treated with neurological system, musculoskeletal system, mental, infectious diseases and malignant tumors
- •Those who have clinically significant respiratory diseases findings as a result of chest X-ray shooting
- •Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma
- •Chronic bronchitis (BCSS 9 or more points or more Those who have continuous cough, sputum symptoms for more than 3 months)
- •A person who has a respiratory symptom due to virus or bacteria within 4 weeks of visit (Influenza, Corona Virus infection 19, pneumonia, acute infection, etc.) However, if the corona virus infection 19 has worsened or new symptoms of respiratory symptoms occur (However, if there are no additional respiratory symptoms caused by corona-19 infections, you can participate after 4 weeks after isolation. In the case of additional respiratory symptoms, the symptoms improve and can be participated if they have been restored to the time of recovery so that there is no difference compared to before infection.)
- •Those who take drugs for the purpose of taking immunosuppressive agents, or for the purpose of regulating Jinhae expectoration within 4 weeks of visit.
- •Those who take health functional foods related to improvement of respiratory health within 2 weeks of visit 1
- •Those who administered antibiotics within 2 weeks of visiting 1
- •Probiotics and those who consistently consume lactic acid bacteria products (4 or more times a week) within 2 weeks
- •Those who are less than 6 months after smokers or smoking cessation
- •Less than 4 weeks of visit, a person who falls under alcohol with an average of 30 g (210 shares) per day (210 weeks), an average of 20 g or more (140 shares) per day (140 shares)
- •Those who are more than twice the summit of Creatinine.
- •AST (G OT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
- •Inconsidable high blood pressure patients systolic blood pressure 160 mmHg or higher or relaxation blood pressure 100 mmHg or higher, test target 10 minutes stabilization
- •Ungodined diabetic patient empathy 180 mg/dL or more
- •Those who are pregnant or have a planning plan for lactation or this human application period
- •Those who have been administered to include other arbitral clinical trial applications within 3 months of visitor and have received food for adoption of drugs for clinical trials. Those who plan to participate
- •Those who are sensitive or allergic to food ingredients for this human application
- •Those who judge that the tester is inadequate for other reasons
研究组 & 干预措施
GCWB1001
Experimental
1 capsule once a day
干预措施: Lactobacillus plantarum (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 BCSS
时间窗: week -2, 6 and 12
The comparison of the bcss change in the before and after the intake of the BCSS is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.
次要结局
- Change amoust of SGRQ(week -2, 6 and 12)
- Change amoust of Lung function (FVC, FEV1, FEV1/FVC)(week -2, 6 and 12)
- Change amoust of VAS(week -2, 6 and 12)
- Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)(week -2 and 12)
研究者
研究点 (4)
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