sleep disorder
Conditions
Interventions
Traditional Chinese Medicine group:Take Qinlian Wendan Tang decoction, one packet at 2 PM and 8 PM daily, for a four-week course
Western medicine group:Take 1mg of Estazolam tablet every night before bedtime with a treatment course of 4 weeks
Healthy control group:None
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: A. Meets the diagnostic criteria for insomnia disorder as defined by DSM-5; B. Adults aged between 18 and 65 years (inclusive of 18 and 65 years); C. Patients with a PSQI score of 8-15 (including 8 and 15) indicating mild to moderate insomnia; D. Voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: A. Individuals with systemic conditions such as pain fever cough or surgery that may contribute to insomnia; B. Patients with severe primary diseases of the cardiovascular pulmonary hepatic renal hematological or immune systems as well as psychiatric disorders; C. Those who have used hormones or immunosuppressants within the last 2 months taken SSRI/SNRIs or MAO inhibitors within the last month or used sedative-hypnotic drugs within the last 2 weeks which may affect the outcome measures; D. Patients with psychiatric disorders such as depression or severe anxiety who are at risk of suicide (PHQ-9 score > 9 or a score of 1 or higher on item 9); E. Women of childbearing age who may become pregnant are currently pregnant or are breastfeeding during the trial period; F. Individuals who are not currently using antibiotics have not used antibiotics within the 4 weeks prior to baseline have not taken over-the-counter probiotics for at least 2 weeks before baseline and are not taking any supplements; G. Exclusion of other organic diseases (e.g. cancer tuberculosis intestinal tuberculosis gastrointestinal disorders and diseases of other organ systems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) Syndrome Score Scale;Pittsburgh Sleep Quality Index (PSQI);The abundance of gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Generalized Anxiety Disorder-7 (GAD-7);Self-Rating Depression Scale;Perceived Deficits Questionnaire-Depression;Polysomnography;Self-Rating Anxiety Scale;Patient Health Questionnaire-9 (PHQ-9); | — |
Countries
china
Contacts
Public Contactliuwenjuan
The Seventh People's Hospital of Hangzhou City
Outcome results
None listed