chronic insomnia
Conditions
Sponsors
Shanghai Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. according to the diagnostic criteria of chronic insomnia in ICD-11; 2. according to Tcm Syndrome differentiation combined with TCM symptom scale of insomnia, the scores of insomnia >=12 (insomnia degree was 12 as baseline, >=12 as insomnia, >=18 as moderate insomnia, >=24 as severe insomnia); 4. aged 18 to 80 years, known and agree to be visited during follow-up; 5. not taking sleeping pills, not taking any sleeping and psychotropic drugs for nearly 2 weeks; 6. conscious, stable vital signs, with certain ability of expression and execution, able to complete the test and treatment.
Exclusion criteria
Exclusion criteria: 1. those who do not meet the inclusion criteria, excluding serious secondary insomnia; 2. Total score of Hamilton Anxiety Rating Scale >=14; 3. Total score of Hamilton Depression scale (Hamd, 17 items)>=18; 4. patients who need to take 2 or more traditional Chinese and Western medicines regularly for a long period of time for the treatment of Insomnia; 5. those who take long-term psychoactive drugs that affect the function of central nervous system, such as antidepressants, anti-schizophrenia drugs and sedative-hypnotic drugs before screening, and do not maintain a stable dosage for at least 4 weeks before screening in this study; 6. those who have serious diseases such as cardiovascular, lung, liver, kidney, or hematopoiesis system, endocrine system, mental disorders, cerebral organic diseases and drug abuse or obvious disorders of vision and hearing; 7. pregnant or lactating women; 8. alcoholism or drug dependence; 9. allergy to the drugs used or contained in the trials of this programme; 10. clinical trials of other drugs, or of any drugs (excluding vitamins and minerals) , 1 month prior to screening; 11. failure to complete the trials or for reasons considered by the researchers not to be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI;MEQ;HAS;sleep diary;TCM Syndrome Score Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA;HAMD; | — |
Countries
China
Contacts
Public ContactXu Jian
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed