The Effect of Adaptogen Elixir on Sleep Improvement

Last updated: April 10, 2025
Sponsor: TCI Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Restless Leg Syndrome

Insomnia

Panic Disorders

Treatment

Adaptogen Elixir drink

Placebo drink

Clinical Study ID

NCT06279312
N202311065
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 pastmonth.

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding women.

  • Individuals with significant organic diseases such as organ transplants, epilepsy orseizures, liver or kidney diseases, malignant tumors, endocrine disorders, or ahistory of alcohol or substance use disorders.

  • Individuals known to be allergic to any components of the product.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Adaptogen Elixir drink
Phase:
Study Start date:
February 26, 2024
Estimated Completion Date:
April 01, 2025

Connect with a study center

  • Taipei Medical University

    Taipei,
    Taiwan

    Site Not Available

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