Short -term Insomnia
Conditions
Interventions
Test group A:Half an hour after breakfast, oral Two bottles of Luo Hua Anshen oral liquid placebo (1/10 of the effective dose ) , and half an hour before going to bed, oarl two bottles of Luo Hua Ansh
Test group B:Half an hour after breakfast, oral Two bottles of Luo Hua Anshen oral liquid , and half an hour before going to bed, oarl two bottles of Luo Hua Anshen oral liquid placebo (1/10 of the e
Test group C:Oarl two bottles of Luo Hua Anshen oral liquid placebo (1/10 of the effective dose ),twice a day.
Health Group D:N/A
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for for Meets the diagnostic criteria for Syndrome of depressed liver qi transforming into fire type sleeplessness in the "Clinical Practice Guidelines for Insomnia in Traditional Chinese Medicine (WHO/WPO)" and the diagnostic criteria for short-term insomnia disorder in DSM-5; 2. Age 18~40 years old (including 18 years old and 40 years old), regardless of gender; 3. Pittsburgh Sleep Quality Index (PSQI) score=6 points; 4. The course of this onset is more than 2 weeks 5. Clear consciousness, stable vital signs, certain expression and execution ability, able to cooperate with the completion of testing and treatment. 6. Voluntarily participate in the research of this project and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The total score of the Hamilton Depression Scale (HAMD, 17 items) is = 18 points and/or Hamilton Anxiety Scale > 14; 2. Those who suffer from other mental disorders and are unstable and/or suicidal and at risk; 3. Add or change previously taken psychotropic drugs that affect central nervous system function (such as antidepressants, non-benzodiazepines, etc.) within 2 weeks before enrollment; 4. Laboratory tests and electrocardiogram have obvious clinically significant abnormalities, which the investigator determines can affect drug evaluation or the safety of subjects; 5. Women who were pregnant or lactating at the time of study and follow-up; 6. Caffeine, alcohol or drug addicts; 7. Those who are allergic to the experimental medication or ingredients contained in this protocol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scale;Insomnia Severity Index Scale;GENEActiv;Sleep diary;Serum specimen metabolomics full-spectrum detection;MEQ-5;HAMA;Morisk Drug Adherence Scale;Participant treatment satisfaction questionnaire;Security metrics;Adverse event assessment form;Blinded assessment questionnaires; | — |
Countries
China
Contacts
Public ContactWenjing Zhang
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed