Difficulty initiating sleep
Conditions
Interventions
Test group:use Spaelay Ginkgo nut (Ginkgo biloba seed) aqueous extract
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age 25–55 years, male or female; 2. Individuals who self-report difficulty initiating sleep and/or nocturnal awakenings but do not meet the diagnostic criteria for insomnia disorder, representing a subhealthy sleep population, including: • nocturnal awakenings >=2 times per night, but occurring on fewer than 3 nights per week; • a duration of sleep-related problems of less than 3 months; • absence of significant daytime functional impairment; • and without a clinical diagnosis of insomnia disorder; 3. Average nightly sleep duration =5; 4. No use of sleep-promoting medications, melatonin, or sleep-affecting dietary supplements within the past month; 5. Physically healthy, without serious chronic diseases; 6. Voluntary participation in the study with signed informed consent and ability to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Individuals with a confirmed diagnosis of insomnia, depression, anxiety, or other psychiatric disorders; 2. Those taking antidepressants, anxiolytics, antihistamines, or sedative medications; 3. Shift workers or individuals who have recently experienced severe jet lag; 4. Women who are pregnant, breastfeeding, or planning to become pregnant; 5. Individuals allergic to Ginkgo products or with a history of severe drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep latency;;Changes in light and deep sleep duration;AI-detected micro-arousals;Subjective sleep quality: changes in total PSQI score.;Changes in total sleep time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Product safety (liver and kidney function, ECG changes, adverse events);Product satisfaction questionnaire.;Psychological assessments (Athens Insomnia Scale, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale);; | — |
Countries
China
Contacts
Public ContactYang Gao
Shanghai Fengxian District Central Hospital
Outcome results
None listed