Status:
NOT_YET_RECRUITING
The Effect of Avnace eZZe on Sleep Improvement
Lead Sponsor:
TCI Co., Ltd.
Conditions:
Sleep Disorder (Disorder)
Anxiety Depression Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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;
- All medications or interventions for insomnia, mental or physical disorders must have been stable for at least four weeks prior to screening, and participants had to be willing to maintain a stable regimen throughout the study;
- No consumption of sleep or stress-related supplements for at least four weeks prior to screening;
- Willing and able to comply with all aspects of the protocol.
Exclusion
- 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;
- Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.);
- Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study;
- History of drug or alcohol dependency or abuse within approximately the previous 2 years;
- Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological, or psychiatric disease or malignancy or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments;
- Scheduled for major surgery during the study;
- Participants known to be allergic to any components of the product.
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07172607
Start Date
September 9 2025
End Date
June 30 2026
Last Update
September 15 2025
Active Locations (1)
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1
Taipei Medical University
Taipei, Taiwan, 110