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 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Factors influencing health status and contact with health services
- 发起方
- Sungkyunbiotech
- 入组人数
- 150
- 状态
- 招募中
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
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\.
结局指标
主要结局
未指定
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