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

NCT07414381 | Completed

• 1 other identifier: CH2501-A-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorders

Keywords

Sleep disorders; GABA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Chenghuang Circadian Rhythm Regulator arm

EXPERIMENTAL

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

Interventions

Chenghuang Circadian Rhythm Regulator DIETARY_SUPPLEMENT

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

Chenghuang Circadian Rhythm Regulator arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead

Study Sites (1)

Shanghi Mengchao Cancer Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Zhicai Lin

  Shanghai Cell Therapy Group Co.,Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 17, 2026
• Study Start: June 6, 2025
• Primary Completion: July 18, 2025
• Study Completion: September 2, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)