KCT0007750招募中未知
A 8-week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of LTC-022 on Improvement of sleep quality
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 40
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
- 30(Year) 至 59(Year)（—）
- 性别
- All
入选标准
- •(1) Aged between 30 and 59 years old.
- •(2) Those with Pittsburgh Sleep Quality Index (PSQI) score of grater than 5.
- •(3) Those with Insomnia Severity Index (ISI) score between 8 and 21.
- •(4) Those who agreed to participate and signed the informed consent form.
排除标准
- •(1) Those with severe diseases in cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease, or malignant tumor.
- •(2) Those who are being treated for sleep disorders (Insomnia, Narcolepsy, Obstructive sleep apnea, Restless Legs Syndrome, Periodic Limb Movement Disorder, etc.) within 4 weeks at visit 1 (Those who administered sleep medications within 4 weeks, Those who are currently under treatment of continuous positive airway pressure at visit 1)
- •(3) Those with major depressive disorders, generalized anxiety disorders, post-traumatic stress disorders, or obsessive-compulsive disorder according to the DSM-V criteria.
- •? Those with PHQ-9 score 10 or higher at visit 1.
- •? Those with GAD-7 score 5 or higher at Visit 1.
- •(4) Those with past or current history of schizophrenia or bipolar disorder.
- •(5) Those with disease of cognitive decline, such as dementia or Parkinson’s diseases, or head trauma accompanied by loss of consciousness/convulsions.
- •(6) Those who took medications that could affect sleep (antipsychotics, antidepressants, anti-anxiety drugs, sleep medications, melatonin, stimulants, beta-blockers, bronchodilators, antihistamines, etc.) within 4 weeks of visit 1.
- •(7) Those who took oral steroids within 4 weeks of visit 1.
- •(8) Those who took dietary supplements related to sleep improvement within 4 weeks of visiting 1.
- •(9) Those who are sensitive or allergic to the ingredients of the clinical trial (those with hypersensitivity to milk and dairy products).
- •(10) Those with body mass index (BMI) 30 kg/m2 or higher at visit 1.
- •(11) Those with alcohol use disorder and who are being treated by hospitalization, medications, or rehabilitation.
- •(12) Those with irregular sleep patterns within 4 weeks due to the shift or night work at visit 1.
- •(13) Those who have participated in other interventional clinical trials within 4 weeks of visit 1 or plan to participate in other interventional clinical trials after the start of this clinical trial.
- •(14) Those who are pregnant, lactating women, or planning pregnancy during the clinical trial period.
- •(15) Those who determined to be not appropriated to participate for other reason by the investigators.
研究者
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