This is a single arm, open-label, self-controlled clinical study to evaluate the sleep and immunity improvement of Chenghuang Circadian Rhythm Regulator in adult subjects with sleep disorders.
This single arm, open-label, self-controlled study aims to evaluate the improvement of sleep and immunity in subjects with sleep disorders following a 4-week intervention with Chenghuang Circadian Rhythm Regulator, which is a combination of Chenghuang Melatonin Tablets and Chenghuang GABA Complex Solid Beverage. The primary endpoint is the Pittsburgh Sleep Quality Index(PSQI) global score, the secondary endpoints are PSQI item score, sleep parameters from actigraphy and serum immune markers. The study will enroll subjects with self-reported sleep disorders and PSQI score \> 7 at screening. The protocol includes a 3-day baseline evaluation period, after which subjects will commence daily administration of the study product 30-60 minutes before bedtime for 4 weeks.The PSQI score was evaluated once a week and actigraphy-derived sleep indices will be monitored daily. The serum Immune markers will be measured at baseline, D14, D28.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
15
Chenghuang Circadian Rhythm Regulator was administered by PO daily 30-60 mins before bed time for 4 weeks
Shanghi Mengchao Cancer Hospital
Shanghai, China
The global score of Pittsburgh Sleep Quality Index (PSQI)
Higher PSQI scores indicate worse sleep quality. PSQI score ranges from 0 to 21
Time frame: Baseline, Day 7, 14, 21, 28
The sleep latency time
Time frame: Baseline, Day7, 14, 21, 28
Actigraphy-derived sleep parameters including night awakening times
Time frame: Baseline, Day 1- Day 28
The count and percentage of immune cells including T cell subsets, B cells, NK cells
Time frame: Baseline, Day 14, 28
Cytokines including interleukin -1β, 2, 4, 5, 6, 8, 10, 12p70, 17/tumor necrosis factor-a/ interferon-a, r
Time frame: Baseline, Day14, 28
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