Sleep Disorders
Conditions
Interventions
Intervention Group:Subjects take two tablets one hour before bedtime daily, once daily, for 14 consecutive days.
Sponsors
Northwestern University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18-55 years, gender unrestricted; (2) Subjective report of sleep problems, with a total Pittsburgh Sleep Quality Index score > 7 (indicating definite sleep disorders); (3) Insomnia duration exceeding 1 month; (4) Voluntary signing of the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals with severe organic diseases (such as severe heart, liver, or kidney dysfunction, sleep apnea syndrome, etc.) or mental disorders; (2) Those with known allergies to ziziphus spinosa or any components/adjuncts in the product; (3) Pregnant, breastfeeding women, or those planning pregnancy; (4) Participants who have been involved in other clinical trials within the past month; (5) Individuals who have regularly used any hypnotic, sedative drugs, or traditional Chinese medicine/health supplements with sedative functions (such as melatonin-containing health supplements) within the past 2 weeks prior to screening; (6) Other situations deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) Questionnaire;cortisol;Wristband Monitoring: Sleep Duration, Proportion of Each Sleep Stage, Sleep Quality Score.; | — |
Countries
China
Contacts
Public ContactXue Mei You
Northwestern University First Hospital
Outcome results
None listed