NCT07414381

An Exploratory Study of Chenghuang Circadian Rhythm Regulator in Subjects With Sleep Disorders

An Exploratory Study of Chenghuang Circadian Rhythm Regulator to Improve Sleep and Immunity in Subjects With Sleep Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chenghuang Circadian Rhythm Regulator	Chenghuang Circadian Rhythm Regulator was administered by PO daily 30-60 mins before bed time for 4 weeks

Timeline

• Start date: 2025-06-06
• Primary completion: 2025-07-18
• Completion: 2025-09-02
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China