Primary insomnia
Conditions
Interventions
Experimental group:Granule of YiShenShuMian
Control group:Low dose granule of YiShenShuMian
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) It meets the diagnostic criteria of primary insomnia in the Chinese Classification and Diagnostic Criteria of Mental Disorders (3rd edition); 2) TCM syndrome differentiation combined with TCM syndrome scale for insomnia was consistent with insomnia; 3) The improved SPIEGEL scale test score =12 points (the degree of insomnia was defined as 12 points for baseline, =12 points for insomnia, =18 points for moderate insomnia, and =24 points for severe insomnia). ; 4) Outpatients aged 18-80 years with informed consent for follow-up observation; 5) She has not taken sleeping pills and has not taken any sleeping or psychotropic drugs in the past 2 weeks; 6) Clear consciousness, stable vital signs, certain ability of expression and execution, able to complete the test and treatment.
Exclusion criteria
Exclusion criteria: 1) Those who did not meet the inclusion criteria were excluded from severe secondary insomnia; 2) Hamilton Anxiety Scale (HAMA) score =14; 3) Hamilton Depression Scale (HAMD, 17 items) score =18; 4) Those who need to regularly take two or more kinds of Chinese and western medicine with insomnia effect; 5) Patients who had taken psychotropic drugs affecting central nervous system function for a long time before screening, such as antidepressants, antischizophrenics and sedative and hypnotic drugs, and did not maintain a stable dose of medication at least 4 weeks before screening in this experiment; 6) Patients with cardiovascular, lung, liver, kidney, or hematopoietic system, endocrine system and other serious diseases, mental disorders, organic brain diseases, drug abuse or obvious visual and hearing disorders; 7) Pregnant or lactating women; 8) Alcoholism or drug dependence; 9) Those who are allergic to the experimental drugs or the ingredients contained in this protocol; 10) Participants in clinical trials of other drugs, or participants in clinical trials of any drug (excluding vitamins and minerals) in the month prior to screening; 11) unable to complete the study or otherwise considered by the investigator to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Questionnaire;SD;TCM Syndrome Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| MEQ;HAS;Modified SPIEGEL scale;SAS; | — |
Countries
China
Contacts
Public Contactjianxu
Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM
Outcome results
None listed