insomnia disorder
Conditions
Interventions
Experimental group (Intervention part):Shuhe Granule
Control group (Intervention part):Placebo
Healthy control group (Cross-sectional part):No
"zhoujing" insomnia group (Cross-sectional part):No
"non-zhoujing" insomnia group (Cross-sectional part):No
Sponsors
Guangdong Provincial Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. For insomnia disorder: (1) 18-70 years old; (2) In line with the Western diagnostic criteria for insomnia disorders; (3) Total score of PSQI > 7; (4) Sign informed consent; 2. Healthy control group: (1) 18-70 years old; (2) No complaints of insomnia; (3) Total score of PSQI < 7; (4) Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. For insomnia disorder: (1) Based on the history and consultation, the doctor confirms secondary insomnia caused by another disease. For example: local pain, restless leg syndrome, moderate to severe sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis; (2) Complicated with serious and unstable diseases of cardiovascular, cerebrovascular, lung, liver, kidney and endocrine system; (3) Patients with anxiety disorder, depression disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder and other mental disorders affecting sleep (using DSM-5 based self-compiled interview tools); (4) Weekly high-intensity exercise (do 4 to 6 times, 30-second high-intensity sprints with certain difficulty, rest for 4 minutes at each interval, and train for 3 days a week); (5) Taking sedative hypnotic drugs and other psychiatric drugs in the past 2 weeks; (6) Pregnant or lactating women; (7) Other situations not suitable for inclusion in the study. 2. Healthy control group: (1) Meet the diagnostic criteria of any disease in DSM-4; (2) Complicated with serious diseases of cardiovascular, cerebrovascular, lung, liver, kidney and endocrine system; (3) Weekly high-intensity exercise (do 4 to 6 times, 30-second high-intensity sprints with certain difficulty, rest for 4 minutes at each interval, and train for 3 days a week); (4) Regular use of sedative hypnotic drugs and other psychiatric drugs in the past two weeks; (5) Pregnant or lactating women; (6) Other situations not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Energy metabolomics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Montreal Cognitive Assessment;Fatigue severity scale;Generalized Anxiety Scale-7;Insomnia Severity Index; | — |
Countries
China
Contacts
Public ContactZhimin Yang
Guangdong Provincial Hospital of TCM
Outcome results
None listed