KCT0006865招募中未知
A 8-week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KBL396 on improvement of Sleep quality in adults with Sleep disorders, Stress, Anxiety, and Depression
Kobiolabs0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 105
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 65?(Year)（—）
- 性别
- All
入选标准
- •1) Men and women over 19 and under 65
- •2) A person whose Pittsburgh sleep quality inventory- Korean version (PSQI-K) is 5 or more
- •3) A person whose stress response inventory (SRI) scale is 81 or more and has 120 or less points
- •3) A person who belongs at least one of those two
- •(1) A person whose Korean-Beck Anxiety scale (K-BAI) is 16 or more points and 45 or less
- •(2) A person whose Korean-Beck Depression Inventory-II (K-BDI-II) scale is 20 or more and 45 or less
- •5) A person who agrees to participate in this human body application test before the human body application test begins and has signed the Informational content
排除标准
- •1) A person who is currently being treated for severe disorders of cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary tract, kidney and urinary system, musculoskeletal system, infectious diseases and malignant tumors
- •2) A person who has been diagnosed with mental illness such as schizophrenia and bipolar disorder
- •or has been diagnosed as a mental patient such as schizophrenia and bipolar disorder
- •3) A person who is currently being treated for major depression, generalized anxiety disorder, post-traumatic stress disorder, and obsessive-compulsive disorder, etc., on the basis of DSM-V
- •4) A person who is being treated for inflammatory bowel disease based on visit 1
- •5) A person who is suffering from mental illness such as schizophrenia or bipolar disorder or have a medical history
- •6) A person who is being treated for dementia within 3 months based on visit 1
- •7) A person who is being treated for sleep disorder within 4 weeks based on visit 1 (Insomnia, Periodic Limb Movement in Sleep (PLMS), Restless leg syndrome (RLS), Sleep apnea, etc.) including treatment method such as sleeping pills, positive pressure devices, etc.)
- •8) A person whose body mass index (BMI) is 35 kg/m2 or more at visit 1
- •9) A person who shows withdrawal symptoms from drinking and smoking
- •10) Current smokers
- •11) A person who has drank excessively in the last 1 month based on visit 1 (men: more than 14 soju/week, women: more than 7 soju/week based on alcohol content)
- •12) A person who has done shift work and night work within 4 weeks based on visit 1 or a person with irregular sleep habits
- •13) A person who has acute stress (dead/marriage/separate/liberation/liberation/discharge/disappear/
- •business failure/critical illness/marriage, etc.) within four weeks of the start of the test14) Those who visit a place with time difference within 4 weeks of visit 1
- •15) A person who took oral steroids and adrenal cortex hormones within four weeks of the start of a
- •16) A person who administered immune-suppressants within 4 weeks based on visit 1
- •17) A person who administered whole-body antibiotics within 2 weeks based on visit 1
- •18) A person who took probiotics and lactic acid bacteria products or intestinal agents continuously (4 times a week or more) within 2 weeks based on visit 1
- •19) A person who took drugs that affect sleep (anticonvulsants, antidepressants, beta blockers, bronchodilators, stimulants, Melatonin, sedative antidepressant, antihistamines, antipsychotics, etc.) within 2 weeks based on visit 1
- •20) A person who consumed health functional foods related to improving sleep, stress, anxiety, and depression within 2 weeks based on visit 1
- •21) A person with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for human subjects)
- •22 A person with uncontrolled diabetes (blood sugar of 180 mg/dL or more, or starting a new drug due to diabetes within 3 months)
- •23) A person whose TSH is 0.5 uIU/mL or less or 7.0 uIU/mL or more
- •24) A person who are being treated for thyroid disease or on medication
- •25) A person whose creatinine is more than twice the normal upper limit of the testing institution
- •26) A person whose AST(GOT) or ALT(GPT) is 3 times or more than the normal upper limit of the testing institution
- •27) A person who have participated in other interventional clinical trials (including human app
研究者
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