Chronic insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the International Classification of Sleep Disorders Third Edition (ICSD-3) diagnostic criteria for chronic insomnia; (2) Insomnia Severity Index (ISI) score = 8; (3) Age between 20-60 years old no gender requirement; (4) They should have a good command of Chinese and be able to communicate normally understand the content of the scale and cooperate with the treatment; (5) Have not received any treatment regimen for insomnia in the past 1 month including Western medicines proprietary Chinese medicines Chinese herbal tonics acupuncture tuina cognitive behavioral therapy etc; (6) Agree and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with serious diseases affecting the endocrine system locomotor system autoimmune system infectious diseases diabetes and other metabolic diseases; (2) Individuals with a history of drug alcohol or caffeine addiction; (3) Patients with a confirmed diagnosis of organic digestive system diseases including peptic ulcer peptic cancer cirrhosis of the liver and ulcerative colitis. (4) Individuals who have taken antibiotics steroid hormones or other drugs that affect intestinal flora within the three months prior to the study. (5) Individuals who have experienced substantial changes in diet within the last four weeks such as those engaged in dieting. (6) Individuals who are pregnant breastfeeding or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleepiness Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital anxiety and depression scale;Gastrointestinal Symptom Rating Scale;intestinal flora;Polysomnography;36-Item Short Form Survey;Insomnia Severity Index;plasma;ActiGraph;Sleep Diary;fMRI;HAS;MFI-20; | — |
Countries
China
Contacts
Shuguang Hospital affiliated to Shanghai University of TCM