KCT0007161招募中未知
A 8 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SB-109 on improvement on stress
Sungkyunbiotech0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) men and women over 20 and under 75
- •2) Those with a Stress Response Inventory(SRI) of 50 or more and 115 or less
- •3) If one or more of the depression/anxiety scales apply
- •? Those with Hamilton Depression Scale (HAM-D) of 8 or more and 16 or less
- •? Those with a Hamilton anxiety scale (HAM-A) of 15 or more and 23 or less
- •4) Those who agreed to participate in this clinical trial prior to the beginning of the clinical trial and signed the informed consent form
排除标准
- •Those who meet one or more conditions are excluded from clinical trials.
- •1) Those currently being treated with severe cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious diseases, and malignant tumors.
- •2) Those with alcohol use/inducing disabilities and central nervous system disorders
- •3) Those with a history of schizophrenia
- •4) Those with major depression disorder/mental illness based on DSM-5(The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- •5) Those with withdrawal symptoms of alcohol and smoking prohibition
- •6) Those who are being treated for dementia within 3 months of visit 1.
- •7) Those who are being treated for depression and stress anxiety within 4 weeks of the visit 1.
- •8) Those who have acute stress (family death/imprisonment/divorce/separation/ debt/run away/delinquency/affair/business failure/serious illness/remarriage, etc.) within 4 weeks of visit 1.
- •9) Those who have taken oral steroids and adrenocortical hormones within 4 weeks of visit 1.
- •10) Those who have taken sleeping piils within 2 weeks of visit 1
- •11) Those who have taken health functional foods related to stress improvement within 2 weeks of visit 1.
- •12) Patients with uncontrolled hypertension(systolic blood pressure above 160mmHg or diastolic blood pressure above 100mmHg, clinical trial subjects measured after 10 minutes of rest)
- •13) Patients with uncontrolled diabetes(fasting blood sugar level is 180 or higher, or start taking medications for diabetes within 3 months of visit 1)
- •14) Those who are being treated or taking medications for thyroid disease
- •15) Those whose creatine is more than twice the normal upper limit
- •16) Those whose AST(GOT) or ALT(GPT) is more than three times the normal upper limit
- •17) Those who are pregnant, lactating women, or have a plan of pregnancy during a clinical trial.
- •18) Those who have participated in other interventional clinical trial within one month(30 days) of visit 1 or plan to participate in other interventional clinical trials after participating this clinical trial
- •19) Those who are sensitive to or allergic to the ingredients of this clinical trial food
- •20) those who are judged inappropriate by the researcher for this clinical trial
研究者
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