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This study employs a real-world design to evaluate the sleep-improving efficacy of Dong'e Brand Ejiao Yuanjiang. A total of 66 participants aged 25-55 will be enrolled and assessed after 60 days of continuous use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Dong'e Brand Ejiao Yuanjiang |
|
| control group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dong'e Brand Ejiao Yuanjiang | Dietary Supplement | Dong'e Brand Ejiao Yuanjiang |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Self-Rating Scale of Sleep | At baseline (screening/enrollment), and at 30 and 60 days after enrollment | |
| Pittsburgh Sleep Quality Index | At baseline (screening/enrollment), and at 30 and 60 days after enrollment | |
| Number of awakenings | Number of awakenings is recorded from the data of Smart Band | record everyday from the one day after enrollment to the 60th day |
| Percentage of light sleep | Percentage of light sleep is recorded from the data of Smart Band | record everyday from the one day after enrollment to the 60th day |
| Total Sleep Time | Total Sleep Time is recorded from the data of Smart Band | record everyday from the one day after enrollment to the 60th day |
| Percentage of deep sleep | Percentage of deep sleep is recorded from the data of Smart Band | record everyday from the one day after enrollment to the 60th day |
| Percentage of REM sleep | Percentage of REM sleep is recorded from the data of Smart Band | record everyday from the one day after enrollment to the 60th day |
| Deep sleep continuity | Deep sleep continuity is recorded from the data of Smart Band |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index(ISI) | At baseline (screening/enrollment), and at 30 and 60 days after enrollment | |
| Sleep Disorders Rating Scale(SDRS) | At baseline (screening/enrollment), and at 30 and 60 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | through study completion, an average of 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Li | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41300013 | Background | Li S, Li Y, Xue C, Zhang Y, Tong T, Ouyang Z, Liu D, Cai J, Sun H. Progress in Research on the Mechanism of GABA in Improving Sleep. Foods. 2025 Nov 11;14(22):3856. doi: 10.3390/foods14223856. | |
| 39534260 | Background | Khalid S, Bashir S, Mehboob R, Anwar T, Ali M, Hashim M, Waseem H, Basharat S. Effects of magnesium and potassium supplementation on insomnia and sleep hormones in patients with diabetes mellitus. Front Endocrinol (Lausanne). 2024 Oct 29;15:1370733. doi: 10.3389/fendo.2024.1370733. eCollection 2024. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo |
| Other |
Placebo |
|
| record everyday from the one day after enrollment to the 60th day |
| Fatigue Scale-14 | At baseline (screening/enrollment), and at 30 and 60 days after enrollment |
| Serum γ-aminobutyric acid | Serum γ-aminobutyric acid | At baseline (screening/enrollment), and at 30 and 60 days after enrollment |
| Melatonin | At baseline (screening/enrollment), and at 30 and 60 days after enrollment |
| Cortisol | At baseline (screening/enrollment), and at 30 and 60 days after enrollment |
| Score of product usage experiences | a questionnaire about product experiences, max score is 50, min score is 0 | record weekly over the past 7 days |
| Background | 1)参考《保健食品功能检验与评价方法(2023)》 |
| D001523 |
| Mental Disorders |