insomnia
Conditions
Interventions
"Sanzang Tiaoshen" experimental group:"Sanzang Tiaoshen" comprehensive treatment of traditional Chinese medicine
Western medicine standard control group:Dexzopicloner
Sponsors
Shenzhen Luohu Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 117 Years
Inclusion criteria
Inclusion criteria: 1) Meets the diagnostic criteria for chronic insomnia in ICSD-3; 2) Age>18 years old; No gender restrictions; 3) PSQI sleep scale>7 points; 4) Can complete scale assessment under the guidance of a physician. 5) Participants voluntarily joined this study understood the research requirements and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals known to be allergic to the investigational drug or its excipients; 2) Serious mental disorders including anxiety depression bipolar disorder suicidal tendencies etc; 3) History of alcohol opioid and amphetamine addiction or dependence; 4) Undertaking other psychological treatments for chronic insomnia; 5) Shift workers year-round night shift workers frequent cross time zone pilots; 6) Pregnant or lactating women; 7) Individuals who have participated in other interventional clinical trials within 4 weeks prior to their first administration; 8) Due to other reasons the researchers determined that participants were not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;Insomnia Severity Index;the 12-items Short Form Health Survey;Mini-Mental State Examination;Dysfunctional Beliefs and Attitudes about Sleep Scale;Montreal Cognitive Assessment;resting state functional magnetic resonance imaging;Sleep Diary; | — |
Countries
China
Contacts
Public ContactWuHongyan
Shenzhen Luohu Hospital of Traditional Chinese Medicine
Outcome results
None listed