An Exploratory Study of Chenghuang Circadian Rhythm Regulator in 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.