Mild Sleep Disorder
Conditions
Interventions
Study Product Group:Consume one sachet of the study product nightly according to the product label instructions for 4–6 weeks.
Placebo Group:Consume one sachet of a placebo product nightly according to the product label instructions, ensuring the placebo is identical in appearance and taste to the study product, for a duratio
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: Adults aged 60 to 80 years; 2.BMI: Body Mass Index (BMI) between 18 and 30 (exclusive of 18 and 30); 3.Sleep Issues: Mild sleep disturbances and/or subjective complaints, including but not limited to difficulty falling asleep, difficulty maintaining sleep, increased nighttime awakenings, or related symptoms; 4.PSQI Score: Pittsburgh Sleep Quality Index (PSQI) score >7 at screening; 5.PHQ-4 Status: Patient Health Questionnaire-4 (PHQ-4) score <=3 (negative for anxiety/depression) at screening; 6.Language and Compliance:Sufficient proficiency in Chinese to complete informed consent and study documentation.Willingness to adhere to the study protocol. 7.Technical Requirements:Ability to install and use a designated security platform on a smartphone during the study. Stable internet connectivity via smartphone.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1.Current Sleep Treatments: Currently receiving pharmacological or non-pharmacological treatments for sleep disorders, including but not limited to hypnotics, traditional Chinese medicine (TCM), or TCM therapies; 2.Primary Sleep Disorders: Self-reported or medically diagnosed primary sleep disorders, including but not limited to:Parasomnias,Sleep apnea (e.g., obstructive sleep apnea, OSA),Narcolepsy,Periodic limb movement disorder (PLMD),Restless legs syndrome (RLS),REM sleep behavior disorder. 3.Medications Affecting Sleep: Continuous use of medications impacting sleep (e.g., CNS stimulants, antidepressants, antipsychotics) for >=3 months prior to screening; 4.Sleep-Related Supplements: Use of dietary supplements affecting sleep (e.g., melatonin, GABA, Ziziphus spinosa) within 4 weeks prior to screening or during the study; 5.High Caffeine Intake: Average daily consumption of >=5 cups (200 mL/cup) of caffeinated beverages (e.g., coffee, tea, energy drinks) within 4 weeks prior to screening or during the study. 6.Sedative Use: Use of sedatives within 4 weeks prior to screening; 7.Antibiotic Use: Use of antibiotics within 4 weeks prior to screening; 8.Allergy/Intolerance: Known allergy or intolerance to the study product and/or its ingredients; 9.Substance Abuse: History of drug abuse or alcohol/psychoactive substance abuse; 10.Shift Work: Night shift workers or individuals with irregular work schedules; 11.Comorbid Conditions: Any physical, psychological, or social condition that, in the investigator’s judgment, may interfere with study participation or outcome evaluation; 12.Special Populations:Pregnant or lactating women deemed unsuitable by the investigator;Caregivers responsible for infants (<=3 years old) during nighttime; 13.Concurrent Trials: Participation in any other clinical trial involving investigational or marketed products within 4 weeks prior to enrollment or during the study; 14.Non-Compliance: Unwillingness to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (Chinese version; CPSQI) Score;Pittsburgh Sleep Quality Index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consumer satisfaction was assessed via questionnaires at the end of the study; | — |
Countries
China
Contacts
Public ContactYin Guoping
Beijing Tsinghua Changgung Hospita
Outcome results
None listed