Status:
COMPLETED
Alpha-s1 Casein Hydrolysate on Sleep
Lead Sponsor:
Kuang Tien General Hospital
Conditions:
Chronic Insomnia
Polysomnography
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysom...
Detailed Description
During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.
Eligibility Criteria
Inclusion
- age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
- PSQI score greater than 5;
- participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.
Exclusion
- currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
- patients with a history of significant head trauma;
- individuals with alcohol abuse within the past year;
- those with other severe medical conditions (e.g., hepatic or renal dysfunction);
- Pregnant women or breastfeeding mothers;
- participants unable to comply with the trial schedule;
- individuals on a vegetarian diet;
- those with allergies to dairy products.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06199596
Start Date
May 1 2019
End Date
November 30 2023
Last Update
January 10 2024
Active Locations (1)
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1
Kuang Tien General Hospital
Taichung, Taiwan, 433