Emotional Medicine
Conditions
Interventions
Group 2:water-fire co-operation method
Group 2:without water-fire co-operation method
Group 3:Esazolam tablets for treatment
Group 4:Zolpidem tablets for treatment
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. It conforms to the diagnostic criteria of CID in the International Classification of Sleep Disorders (Third Edition) formulated by the American Sleep Medical Association; 2. Meet the diagnostic criteria of insomnia caused by heart-kidney disharmony in Internal Medicine of Traditional Chinese Medicine (9th Edition); 3. Age 18-65 years; 4. The score of Insomnia Severity Index, ISI) is >= 8.
Exclusion criteria
Exclusion criteria: 1. Secondary insomnia, including mental disorders, physical diseases, substance abuse and other sleep disorders; 2. Insomnia caused by depressive disorder and generalized anxiety disorder, in which 9 items of patient health questionnaire (PHQ-9) are more than or equal to 10 points, and 7 items of generalized anxiety disorder scale (GAD-7) are more than or equal to 10 points; 3. Take BzBAs, melatonin receptor agonists, antipsychotics, antidepressants, orexin receptor antagonists, antiepileptic drugs and other drugs for the treatment of insomnia within 4 weeks; 4. The test can't be completed because the inspection doesn't cooperate; 5. It is expected that there will be intolerable or serious adverse reactions, and withdrawal reactions will occur during the follow-up period, so it is necessary to take medicine again; 6. Pregnancy and lactation; 7. Polysomnography (PSG) at night found that the apnea hypopnea index (AHI) was more than 5 or the periodic limb movements index (PLMI) was more than 15.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index, ISI;Patient Health Questionaire-9 item, PHQ-9;Generalized Anxiety Disorder-7, GAD-7;Fatigue Assessment Scale, FAS;Sleep structure related indicators;Th1/Th2 Balance Related Indicators; | — |
Countries
China
Contacts
Public ContactLiu Yi
Hangzhou Seventh People's Hospital
Outcome results
None listed