The Effect of Adaptogen Elixir on Sleep Improvement

NCT06279312 | Completed

• 1 other identifier: N202311065
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Anxiety Disorders

Keywords

Adaptogen

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Neuropeptide Y concentration

  Week 0 (Baseline), Week 2, Week 4

• Cortisol concentration

  Week 0 (Baseline), Week 2, Week 4

• Anxiety

  Week 0 (Baseline), Week 2, Week 4

• Low Frequency/High Frequence (LF/HF) ratio

  Week 0 (Baseline), Week 2, Week 4

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

consume 1 drink per day for 4 weeks

Dietary Supplement: Placebo drink

Adaptogen Elixir drink

EXPERIMENTAL

consume 1 drink per day for 4 weeks

Dietary Supplement: Adaptogen Elixir drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 drink per day for 4 weeks

Placebo drink

Adaptogen Elixir drink DIETARY_SUPPLEMENT

consume 1 drink per day for 4 weeks

Also known as: Isagenix-Adaptogen Elixir

Adaptogen Elixir drink

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hsin-Chien Lee, Doctor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: February 26, 2024
• Primary Completion: July 31, 2024
• Study Completion: April 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)