The Effect of Adaptogen Elixir on Sleep Improvement
- Conditions
- Anxiety DisordersSleep Disorder
- Interventions
- Dietary Supplement: Placebo drinkDietary Supplement: Adaptogen Elixir drink
- Registration Number
- NCT06279312
- Lead Sponsor
- TCI Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo drink Placebo drink consume 1 drink per day for 4 weeks Adaptogen Elixir drink Adaptogen Elixir drink consume 1 drink per day for 4 weeks
- Primary Outcome Measures
Name Time Method Sleeping qualityy 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 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 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.
- Secondary Outcome Measures
Name Time Method Neuropeptide Y concentration Week 0 (Baseline), Week 2, Week 4 Venous blood samples will be collected to measure concentrations of Neuropeptide Y.
Low Frequency/High Frequence (LF/HF) ratio Week 0 (Baseline), Week 2, Week 4 A sleep monitoring system will be utilized to measure LF/HF ratio
Cortisol concentration Week 0 (Baseline), Week 2, Week 4 Saliva samples will be collected to measure concentrations of cortisol.
Anxiety Week 0 (Baseline), Week 2, Week 4 Generalized Anxiety Disorder-7 (GAD-7) will be utilized to assess anxiety. The minimum value is 0, the maximum value is 21. The higher the score, the worse the outcome.
Trial Locations
- Locations (1)
Taipei Medical University
🇨🇳Taipei, Taiwan