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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorders
• Intervention / Treatment: Dietary supplement: Chenghuang Circadian Rhythm Regulator

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghi Mengchao Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

  1. Difficult in sleep onset: sleep actigraphy device report sleep latency ≥ 30 mins;
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chenghuang Circadian Rhythm Regulator arm; A group of subjects who have PSQI score>7 at screening and will be given Chenghuang Circadian Rhythm Regulator for 4 weeks	Dietary supplement: Chenghuang Circadian Rhythm Regulator; Chenghuang Circadian Rhythm Regulator was administered by PO daily 30-60 mins before bed time for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The global score of Pittsburgh Sleep Quality Index (PSQI)	Higher PSQI scores indicate worse sleep quality. PSQI score ranges from 0 to 21	Baseline, Day 7, 14, 21, 28

Secondary Outcome Measures

Outcome Measure	Time Frame
The sleep latency time	Baseline, Day7, 14, 21, 28
Actigraphy-derived sleep parameters including night awakening times	Baseline, Day 1- Day 28
The count and percentage of immune cells including T cell subsets, B cells, NK cells	Baseline, Day 14, 28
Cytokines including interleukin -1β, 2, 4, 5, 6, 8, 10, 12p70, 17/tumor necrosis factor-a/ interferon-a, r	Baseline, Day14, 28

Collaborators and Investigators

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd
• Investigators: Study Director: Zhicai Lin, Shanghai Cell Therapy Group Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Sleep disorders; GABA
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: CH2501-A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No