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.

Inclusion criteria

• Adult subjects complain about significant distress or impairment in social functioning caused by poor sleep;
• Following sleep problems happened ≥ 3 times a week and last for ≥ 1 month:

• Difficult in sleep onset: sleep actigraphy device report sleep latency ≥ 30 mins;
• Or difficult in sleep maintenance: nighttime awakenings ≥2 times; or early morning awakenings; or total sleep duration < 6 hours; or abnormal deep reported by actigraphy device;
• Pittsburgh Sleep Quality Index(PSQI) global score >7;
• Subjects voluntarily agree to participate in this study and have signed the informed consent form.

Exclusion criteria

• Subjects with coagulation dysfunction, severe cardiovascular and cerebrovascular, hepatic, renal, hematological disorders, or psychiatric diseases;
• Pregnant or lactating women;
• Subjects with secondary sleep disorders (e.g., due to depression, anxiety, sleep apnea syndrome, etc.);
• Subjects who received acupuncture, hypnotics or cognitive behavioral therapy for sleep disorder within past 4 weeks;
• Subjects with shift work or a history of transmeridian travel within the past 4 weeks;
• Subjects with diseases, medication use, or swallowing difficulties that may affect gastrointestinal absorption or motility;
• Subjects with diseases or abnormalities assessed by the investigator to potentially affect study results