An Exploratory Study of Chenghuang Circadian Rhythm Regulator to Improve Sleep and Immunity in Subjects With Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The global score of Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This is a single arm, open-label, self-controlled clinical study to evaluate the sleep and immunity improvement of Chenghuang Circadian Rhythm Regulator in adult subjects with sleep disorders.
详细描述
This single arm, open-label, self-controlled study aims to evaluate the improvement of sleep and immunity in subjects with sleep disorders following a 4-week intervention with Chenghuang Circadian Rhythm Regulator, which is a combination of Chenghuang Melatonin Tablets and Chenghuang GABA Complex Solid Beverage. The primary endpoint is the Pittsburgh Sleep Quality Index(PSQI) global score, the secondary endpoints are PSQI item score， sleep parameters from actigraphy and serum immune markers.
The study will enroll subjects with self-reported sleep disorders and PSQI score > 7 at screening. The protocol includes a 3-day baseline evaluation period, after which subjects will commence daily administration of the study product 30-60 minutes before bedtime for 4 weeks.The PSQI score was evaluated once a week and actigraphy-derived sleep indices will be monitored daily. The serum Immune markers will be measured at baseline, D14, D28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects complain about significant distress or impairment in social functioning caused by poor sleep;
- •Following sleep problems happened ≥ 3 times a week and last for ≥ 1 month:
- •Difficult in sleep onset: sleep actigraphy device report sleep latency ≥ 30 mins;
- •Or difficult in sleep maintenance: nighttime awakenings ≥2 times; or early morning awakenings; or total sleep duration < 6 hours; or abnormal deep reported by actigraphy device;
- •Pittsburgh Sleep Quality Index(PSQI) global score >7;
- •Subjects voluntarily agree to participate in this study and have signed the informed consent form.
排除标准
- •Subjects with coagulation dysfunction, severe cardiovascular and cerebrovascular, hepatic, renal, hematological disorders, or psychiatric diseases;
- •Pregnant or lactating women;
- •Subjects with secondary sleep disorders (e.g., due to depression, anxiety, sleep apnea syndrome, etc.);
- •Subjects who received acupuncture, hypnotics or cognitive behavioral therapy for sleep disorder within past 4 weeks;
- •Subjects with shift work or a history of transmeridian travel within the past 4 weeks;
- •Subjects with diseases, medication use, or swallowing difficulties that may affect gastrointestinal absorption or motility;
- •Subjects with diseases or abnormalities assessed by the investigator to potentially affect study results
研究组 & 干预措施
Chenghuang Circadian Rhythm Regulator arm
A group of subjects who have PSQI score>7 at screening and will be given Chenghuang Circadian Rhythm Regulator for 4 weeks
干预措施: Chenghuang Circadian Rhythm Regulator (Dietary Supplement)
结局指标
主要结局
The global score of Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, Day 7, 14, 21, 28
Higher PSQI scores indicate worse sleep quality. PSQI score ranges from 0 to 21
次要结局
- Cytokines including interleukin -1β, 2, 4, 5, 6, 8, 10, 12p70, 17/tumor necrosis factor-a/ interferon-a, r(Baseline, Day14, 28)
- The sleep latency time(Baseline, Day7, 14, 21, 28)
- Actigraphy-derived sleep parameters including night awakening times(Baseline, Day 1- Day 28)
- The count and percentage of immune cells including T cell subsets, B cells, NK cells(Baseline, Day 14, 28)