KCT0008204招募中未知
A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of HDB1258 on Improving Immune Function
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •A person who meets all of the following conditions shall be selected as a person subject to the human body application test.
- •1) A person who is 19 years of age or older and 75 years of age or younger;
- •2) Those with peripheral blood white blood cell count measured in Visit 1 of 4 x 103 cells/µL or more and less than 10 x 103 cells/µL
- •3) A person who falls under one or more of the following criteria
- •? A person who has had at least two upper respiratory tract infections* within one year based on visit 1.
- •*{Cold, Acute Tonsillitis, Pharyngitis, Laryngitis, Rhinitis, etc.)
- •? A person who has had stomatitis more than twice within one year based on visit 1.
- •? Those who have had herpes Zoster infection within one year of visit 1 visit
- •? A person who has had at least 3 cases of simple cystitis within 1 year of visit 1 or more times of simple cystitis within 6 months of visit 1
- •? Person who scored 4 points or more in 6 questions in the Leaky Gut Syndrome questionnaire based on visit 1 for 6 months
- •4) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
排除标准
- •A person who falls under one or more of the following described conditions shall be excluded from the subject of human application tests.
- •1) A person currently being treated for severe cardiovascular, immune, respiratory, hepatometer, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors.
- •2) Those with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, based on measurement after 10 minutes of stability of the test subjects)
- •3) Diabetes patients with fasting blood sugar of 126 mg/dL or higher, glycated hemoglobin (HbA1c) of 6.5% or higher, or anti-diabetic drugs (such as oral hypoglycemic agents, insulin, etc.)
- •4) Those with a TSH of 0.1 µIU/mL or less and 10 µIU/mL or more
- •5) A person who has been vaccinated within two months based on visit 1.
- •6) Those who have been confirmed to be infected with COVID-19 within 2 months based on Visit 1
- •7) A person whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the operator.
- •8) Those whose creatine is 1.5 times or more above the normal upper limit of the implementing institution.
- •9) Person who has used steroids within 4 weeks of visit 1
- •10) Those who have administered antibiotics, immunosuppressants, gastric acid inhibitors, and antihistamines within two weeks of visit 1
- •11) A person who has consumed probiotics and lactobacillus products continuously (at least four times a week) within two weeks of visiting.
- •12) A person who has consumed health functional foods and vitamins that can affect immunity within two weeks of visit 1
- •13) A person who has an average alcohol intake habit of 14 units for men and 7 units for women per week over the past month in the drinking habit survey.
- •14) A person who is being treated for severe allergies or asthma.
- •15) A person who has experienced severe food allergies
- •16) A person who complains of severe gastrointestinal symptoms such as heartburn, indigestion, etc.
- •17) A person who is pregnant or who is lactating or has plans to conceive during this human body application test.
- •18) A person who has participated in another interventional clinical trial (including the human body application test) or plans to participate in another interventional clinical trial (including the human body application test) after the commencement of this human body application test within 8 weeks of visit 1
- •19) A person who is sensitive to or allergic to food ingredients for this human body application test
- •20) Those with a body mass index (BMI) of 30 kg/m2 or more
- •21) A person who is deemed inappropriate by the tester for other reasons.
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