Health Trials

About this trial

This study aims to examine the effectiveness of Avance eZZe drink with liposomal technology in improving sleep quality. Participants will be randomly assigned to either the placebo group, Avance eZZe drink group, and Avance eZZe drink without liposomal group, with 25 participants in each group. On the day of the experiment (day 0), participants are required to 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 1 hour before sleep daily for 28 days. Follow-up assessments will be conducted in the day-1, day-14 and day-28, participants are required to 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

Qualifiers

Male or female age 18 years or older;

Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder;

Regular bedtime, between 21:00 and 01:00 and regular wake time;

Insomnia Severity Index (ISI) score ≥15;

Disqualifiers

A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder;

Depressive symptoms at screening were considered significantly severe with a PHQ-9 score > 14

Anxiety symptoms at screening were considered significantly severe with a GAD-7 score > 15;

Females who are breastfeeding or pregnant;

Trial design

Treatments tested in this trial

  • Avance eZZe drink
  • Avance eZZe drink (without liposomal)
  • Placebo drink

Treatment groups

75 Participants
are divided into 3 treatment groups

Locations

1
Taipei Medical University110, Taipei Taiwan

Sponsors and collaborators

TCI Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov