The Effect of Adaptogen Elixir on Sleep Improvement

NCT ID: NCT06279312

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2025-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo drink

consume 1 drink per day for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo drink

Intervention Type: DIETARY_SUPPLEMENT

consume 1 drink per day for 4 weeks

Adaptogen Elixir drink

consume 1 drink per day for 4 weeks

Group Type: EXPERIMENTAL

Adaptogen Elixir drink

Intervention Type: DIETARY_SUPPLEMENT

consume 1 drink per day for 4 weeks

Interventions

Placebo drink

consume 1 drink per day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Adaptogen Elixir drink

consume 1 drink per day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Isagenix-Adaptogen Elixir

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsin-Chien Lee, Doctor

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202311065

Identifier Type: -

Identifier Source: org_study_id