Chronic insomnia
Conditions
Interventions
Experimental group:acetyl gastrodin tablets
Sponsors
Beijing Huilongguan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5); 2. Age 18-65 years old (including the boundary value), gender is not limited; 3. The subjective total sleep time of at least 3 nights per week in the preceding 3 months was =6 hours/night; 4. Insomnia Severity Index (ISI)=8 points; 5. Can be accompanied by depressive disorder, generalized anxiety disorder, but Hamilton Anxiety scale (HAMA) =14 points, Hamilton Depression scale (HAMD-17) =17 points; 6. Have smart terminal devices (such as smart phones, tablets), and can use wechat and other software smoothly; 7. Volunteer to be tested and sign informed consent, fully understand the content and process of the test, and be able to complete the study according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: 1. Physical diseases such as pain, fever, cough, surgery, etc., as well as secondary insomnia caused by changes in lifestyle habits and external environmental disturbances, and other sleep disorders (such as sleep apnea syndrome, restless leg syndrome, etc.); 2. Complicated with heart, liver, kidney, blood and other serious diseases that affect their survival, such as tumors or AIDS; 3. In addition to insomnia drugs, other long-term stable drugs (such as antidepressants, etc.) have been adjusted within 1 month before screening; 4. Patients who stopped treating insomnia drugs 1.5×ULN); 7. Abnormal renal function (Cr > 1×ULN); 8. Pregnant or lactating women or those who have recently had fertility requirements; 9. Those who regularly drink excessive tea and coffee drinks every day; 10. Special professionals who need to operate machinery during the test, such as professional drivers and high-altitude operators; 11. Any lifestyle that interferes with the course of the trial or may interfere with sleep: such as travel across time zones or shift work (night shift and day shift) in the last two weeks or during the trial period, day and night shift workers; 12. Suspected or confirmed drug abuse, alcohol abuse; 13. There is a severe acute infection and it is not under control; Or have suppurative and chronic infection, prolonged wound does not heal; 14. Serious mental or nervous system disorders that affect informed consent and/or expression or observation of adverse reactions, and cannot cooperate with the completion of the questionnaire; 15. People who are allergic or known to be allergic to the ingredients contained in the investigational drug; 16. Participants who have participated in other clinical trials within 3 months before screening; 17. Participants deemed inappropriate by the investigator to participate in the clinical trial, including but not limited to: the investigator judges that the subject has poor compliance, or lives too far away to follow the interview as scheduled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective sleep Indicators (Smart bracelet);Sleep journal;Clinical global impression Scale;Self-rating sleep quality Scale; | — |
Countries
China
Contacts
Public ContactChen Jingxu
Beijing Huilongguan Hospital
Outcome results
None listed