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Completed

NCT Number: NCT06279312

The Effect of Adaptogen Elixir on Sleep Improvement

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.

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Key information

Conditions

Sleep Disorder Anxiety Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 drink per day for 4 weeks

Adaptogen Elixir drink

Dietary Supplement

consume 1 drink per day for 4 weeks

Other names: Isagenix-Adaptogen Elixir

Primary outcomes

  1. Sleep monitoring

    Time frame: 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.

  2. Sleeping qualityy

    Time frame: 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.

  3. Sleeping disorders

    Time frame: 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.

Secondary outcomes

  1. Neuropeptide Y concentration

    Time frame: Week 0 (Baseline), Week 2, Week 4

    Venous blood samples will be collected to measure concentrations of Neuropeptide Y.

  2. Cortisol concentration

    Time frame: Week 0 (Baseline), Week 2, Week 4

    Saliva samples will be collected to measure concentrations of cortisol.

  3. Anxiety

    Time frame: 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.

  4. Low Frequency/High Frequence (LF/HF) ratio

    Time frame: Week 0 (Baseline), Week 2, Week 4

    A sleep monitoring system will be utilized to measure LF/HF ratio

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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