Sleep DisordersNCT07414381
An Exploratory Study of Chenghuang Circadian Rhythm Regulator in Subjects With Sleep Disorders
A study testing Chenghuang Circadian Rhythm Regulator in people with Sleep Disorders, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Chenghuang Circadian Rhythm Regulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2025to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Chenghuang Circadian Rhythm Regulator
- Keywords
- Sleep disorders, GABA
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chenghuang Circadian Rhythm RegulatorDietary supplement
Chenghuang Circadian Rhythm Regulator was administered by PO daily 30-60 mins before bed time for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Chenghuang Circadian Rhythm Regulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The global score of Pittsburgh Sleep Quality Index (PSQI)
Higher PSQI scores indicate worse sleep quality. PSQI score ranges from 0 to 21
Measured: Baseline, Day 7, 14, 21, 28
Secondary outcomes (4)
The sleep latency time
Measured: Baseline, Day7, 14, 21, 28
Actigraphy-derived sleep parameters including night awakening times
Measured: Baseline, Day 1- Day 28
The count and percentage of immune cells including T cell subsets, B cells, NK cells
Measured: Baseline, Day 14, 28
Cytokines including interleukin -1β, 2, 4, 5, 6, 8, 10, 12p70, 17/tumor necrosis factor-a/ interferon-a, r
Measured: Baseline, Day14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start6 Jun 2025
- Primary completion18 Jul 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhicai Lin, Study director, Shanghai Cell Therapy Group Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414381
- Sponsor's protocol ID
- CH2501-A-01
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Chenghuang Circadian Rhythm Regulator to Improve Sleep and Immunity in Subjects With Sleep Disorders
- ClinicalTrials.gov ID
- NCT07414381
- Acronym / sponsor ID
- CH2501-A-01
- Conditions
- Sleep Disorders
- Keywords
- Sleep disorders, GABA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chenghuang Circadian Rhythm Regulator arm | Experimental | Dietary Supplement: Chenghuang Circadian Rhythm RegulatorA group of subjects who have PSQI score>7 at screening and will be given Chenghuang Circadian Rhythm Regulator for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Pittsburgh Sleep Quality Index(PSQI) global score >7;
- Subjects voluntarily agree to participate in this study and have signed the informed consent form.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chenghuang Circadian Rhythm RegulatorChenghuang Circadian Rhythm Regulator was administered by PO daily 30-60 mins before bed time for 4 weeks | Dietary supplement | Chenghuang Circadian Rhythm Regulator arm |
Primary outcome
The global score of Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Day 7, 14, 21, 28
Higher PSQI scores indicate worse sleep quality. PSQI score ranges from 0 to 21
4 secondary outcomes
The sleep latency time
Time frame: Baseline, Day7, 14, 21, 28
Actigraphy-derived sleep parameters including night awakening times
Time frame: Baseline, Day 1- Day 28
The count and percentage of immune cells including T cell subsets, B cells, NK cells
Time frame: Baseline, Day 14, 28
Cytokines including interleukin -1β, 2, 4, 5, 6, 8, 10, 12p70, 17/tumor necrosis factor-a/ interferon-a, r
Time frame: Baseline, Day14, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhicai Lin study director
Shanghai Cell Therapy Group Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chenghuang Circadian Rhythm Regulator in people with Sleep Disorders, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The global score of Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, Day 7, 14, 21, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.