The Effect of Adaptogen Elixir on Sleep Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Sleeping qualityy
研究概览
简要总结
This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged above 18 years old.
- •Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9).
- •No medication use or regular use of sleeping pills or antidepressants in the past month.
- •No ongoing mental illnesses.
- •No ongoing physical illnesses.
- •No other sleep disorders.
- •No circadian rhythm issues.
- •No consumption of sleep or stress-related supplements in the past month.
排除标准
- •Pregnant or breastfeeding women.
- •Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
- •Individuals known to be allergic to any components of the product.
研究组 & 干预措施
Placebo drink
consume 1 drink per day for 4 weeks
干预措施: Placebo drink (Dietary Supplement)
Adaptogen Elixir drink
consume 1 drink per day for 4 weeks
干预措施: Adaptogen Elixir drink (Dietary Supplement)
结局指标
主要结局
Sleeping qualityy
时间窗: Week 0 (Baseline), Week 2, Week 4
The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.
Sleeping disorders
时间窗: Week 0 (Baseline), Week 2, Week 4
Insomnia Severity Index (ISI) will be utilized to assess sleeping disorders. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.
Sleep monitoring
时间窗: Week 0 (Baseline), Week 2, Week 4
The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.
次要结局
- Neuropeptide Y concentration(Week 0 (Baseline), Week 2, Week 4)
- Low Frequency/High Frequence (LF/HF) ratio(Week 0 (Baseline), Week 2, Week 4)
- Cortisol concentration(Week 0 (Baseline), Week 2, Week 4)
- Anxiety(Week 0 (Baseline), Week 2, Week 4)