chronic insomnia
Conditions
Interventions
Test group:Febrile package
control group:TCM clinical pathway treatment scheme for insomnia
Sponsors
Shanghai Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) It meets the diagnostic criteria of chronic insomnia in ICD-11; 2) TCM syndrome differentiation combined with insomnia TCM symptom scale assessment is consistent with insomnia; 3) The test score of the improved SPIEGEL scale is >= 12 points (the degree of insomnia is based on 12 points, >= 12 points is insomnia, >= 18 points is moderate insomnia, >= 24 points is severe insomnia); 4) Outpatients aged from 18 to 80 years old, informed and agreed to receive follow-up observation; 5) He has not taken sleeping pills and has not taken any sleeping and psychotropic drugs in the past 2 weeks; 6) He has clear mind, stable vital signs, certain expression and execution ability, and can cooperate to complete the test and treatment.
Exclusion criteria
Exclusion criteria: 1) Those who do not meet the inclusion criteria shall be excluded from serious secondary insomnia; 2) Hamilton Anxiety Scale (HAMA) total score >= 14; 3) The total score of Hamilton Depression Scale (HAMD, 17 items) >= 18; 4) Those who need to take 2 or more traditional Chinese and western medicine with insomnia treatment effect regularly for a long time; 5) Before screening, patients who have taken psychotropic drugs that affect the function of the central nervous system for a long time, such as antidepressants, antipsychotics, sedatives and hypnotics, and have not maintained a stable dose of medication at least 4 weeks before screening in this experiment; 6) Those who have serious diseases such as cardiovascular, lung, liver, kidney, or hematopoietic system, endocrine system, mental disease, brain organic disease, drug abuse or obvious impairment of vision and hearing; 7) Pregnant or lactating women; 8) Alcoholics or drug addicts; 9) Those who are allergic to the experimental drug or the ingredients contained in this protocol; 10) Those who are participating in clinical trials of other drugs or have participated in clinical trials of any drugs (excluding vitamins and minerals) one month before screening; 11) Those who are unable to complete the experiment or the researcher believes that they cannot be selected for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| SPIEGEL;TCM Symptom Scale; | — |
Countries
China
Contacts
Public ContactShuyun Xiao
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed