Insomnia
Conditions
Interventions
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Meet the relevant diagnostic criteria for sleep disorders in ICD-10; 2.PSQI scale test score >= 6 points; 3.Between 18 and 60 years old; 4.Sign the informed consent form; 5.Stable vital signs; 6.Conscious, able to cooperate to complete cognitive behavioral therapy.
Exclusion criteria
Exclusion criteria: 1.Secondary insomnia ; 2.Hamilton Anxiety Scale (HAMA) total score >= 14 points; 3.Hamilton Depression Scale (HAMD, 17 items) total score >= 18 points; 4.Those taking psychoactive drugs (anti-depressants, anti-anxiety drugs, etc.) at the same time; 5.Those who have taken sleeping medicines and supplements (melatonin, etc.) regularly within 2 weeks before treatment or during the same period; 6.Those who have serious diseases such as cardiovascular, lung, liver, kidney, or hematopoietic system, endocrine system, mental illness, brain organic disease, drug abuse, or obvious visual or hearing impairment; 7.Laboratory examinations and ECG examinations have obvious clinically significant abnormalities, and according to the investigator's judgment, the abnormalities may affect the drug evaluation or the safety of the subjects; 8.Pregnant or lactating women; 9.Alcoholism or drug dependence; 10.Those who are allergic to the experimental drugs or ingredients contained in this protocol; 11.Those who cannot complete the experiment or the researcher thinks they cannot be selected for other reasons. 12.Those who participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Traditional Chinese Medicine Syndrome Scale;Dysfunctional Beliefs and Attitudes about Sleep;Actigraphy; | — |
Countries
China
Contacts
Public ContactWen-Jing Zhang
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed