Insomnia
Conditions
Interventions
Test group:Yishen Shumian Formula Granules
control group:Placebo granules (1/10 of the effective dose of the treatment group)
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Meets the diagnostic criteria for insomnia and generalized anxiety in ICD-11; 2) With reference to the diagnostic criteria for insomnia in the Guidelines for Diagnosis and Treatment of Common Diseases in Internal Medicine (TCM Diseases and Symptoms) of the China Association of Chinese Medicine, and with reference to the national textbook of TCM education in general higher education during the "12th Five Year Plan", Internal Medicine of Traditional Chinese Medicine (3rd Edition), the assessment of depression syndrome meets the diagnostic criteria for insomnia and depression disease; 3) The improved SPIEGEL scale has a detection score of = 12 points (insomnia degree is based on a baseline of 12 points, with = 12 points indicating insomnia, = 18 points indicating moderate insomnia, and = 24 points indicating severe insomnia); 4) Informed and agreed to undergo follow-up observation for outpatient patients aged 18 to 80; 5) I have not taken any sleeping pills and have not taken any sleeping or psychiatric drugs in the past 2 weeks; 6) Clear consciousness, stable vital signs, possessing certain expressive and executive abilities, able to cooperate in completing tests and treatments.
Exclusion criteria
Exclusion criteria: 1) Those who do not meet the inclusion criteria will be excluded from severe secondary insomnia; 2) The total score of the Hamilton Depression Scale (HAMD, 17 items) is = 18 points; 3) Those who need to regularly take two or more traditional Chinese and Western medicines with therapeutic effects on insomnia for a long time; 4) Patients who have taken psychotropic drugs that affect the function of the central nervous system for a long time before screening, such as antidepressants, antipsychotics and sedative hypnotic, and have not maintained a stable dose of drugs at least 4 weeks before screening in this experiment; 5) Those who have serious diseases such as cardiovascular, pulmonary, liver, kidney, or hematopoietic system, endocrine system, mental disorders, organic brain diseases, drug abuse, or obvious visual and auditory impairments; 6) Pregnant or lactating women; 7) Alcoholics or drug addicts; 8) Individuals who are allergic to the experimental medication or ingredients contained in this protocol; 9) Individuals who are participating in clinical trials of other drugs or have participated in any drug (excluding vitamins and minerals) one month prior to screening; 10) Those who are unable to complete the experiment or are deemed by the researcher to be ineligible for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Hamilton Anxiety Scale;Morning and Evening Questionnaire;Sleep D;Traditional Chinese Medicine Syndrome Scale; | — |
Countries
China
Contacts
Public ContactXiao Shuyun
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed