The Effect of Adaptogen Elixir on Sleep Improvement

Anxiety Disorders Clinical Trial

Official title:

The Effect of Adaptogen Elixir on Sleep Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279312
• Other study ID #: N202311065
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: TCI Co., Ltd.
• Contact: Hsin-Chien Lee, Doctor
• Phone: +886-02-22490088
• Email: ellalee[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Placebo drink
consume 1 drink per day for 4 weeks
• Adaptogen Elixir drink
consume 1 drink per day for 4 weeks

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep monitoring	The difference of electrocardiosignal between two specific points on the body surface will be used to reflect sleep state.	Week 0 (Baseline), Week 2, Week 4
Primary	Sleeping qualityy	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.	Week 0 (Baseline), Week 2, Week 4
Primary	Sleeping disorders	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.	Week 0 (Baseline), Week 2, Week 4
Secondary	Neuropeptide Y concentration	Venous blood samples will be collected to measure concentrations of Neuropeptide Y.	Week 0 (Baseline), Week 2, Week 4
Secondary	Cortisol concentration	Saliva samples will be collected to measure concentrations of cortisol.	Week 0 (Baseline), Week 2, Week 4
Secondary	Anxiety	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.	Week 0 (Baseline), Week 2, Week 4
Secondary	Low Frequency/High Frequence (LF/HF) ratio	A sleep monitoring system will be utilized to measure LF/HF ratio	Week 0 (Baseline), Week 2, Week 4