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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shanghai, China
- Shanghi Mengchao Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
- 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
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)
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
|
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)
Time Frame: Baseline, Day 7, 14, 21, 28
|
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
Time Frame: Baseline, Day7, 14, 21, 28
|
Baseline, Day7, 14, 21, 28
|
|
Actigraphy-derived sleep parameters including night awakening times
Time Frame: Baseline, Day 1- Day 28
|
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
|
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
|
Baseline, Day14, 28
|
Collaborators and Investigators
Investigators
- Study Director: Zhicai Lin, Shanghai Cell Therapy Group Co.,Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH2501-A-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.