insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) It conforms to the diagnostic criteria of chronic insomnia in Chinese Adult Insomnia Diagnosis and Treatment Guidelines (2017 Edition) [25] (Annex 5);2) PSQI scale (Annex 3) score =7 points or ISI scale > 7 points 3) no allergy or intolerance to melatonin milk;4) Volunteer for the experiment.
Exclusion criteria
Exclusion criteria: 1) Patients with malignant tumors, severe heart, liver, renal insufficiency, autoimmune diseases, blood system diseases and other systemic conditions.2) Patients with diseases of nervous system, cardiovascular system, respiratory system, digestive system and endocrine system, physical diseases (itchy skin and chronic pain, etc.).3) Patients with dementia and sensory aphasia due to various reasons who could not cooperate with the study.4) Patients with severe anxiety, depression, mania, schizophrenia and suicidal tendencies.5) Patients who are bedridden for a long time or have serious decline in daily living ability and cannot take care of themselves.6) Patients who are participating in other clinical trials.7) Patients in pregnancy or lactation period.8) Patients with an unnatural lifestyle (such as shift workers and individuals with jet lag);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Severity of insomnia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary metabolome;Serum metabolome;Intestinal flora;Salivary melatonin; | — |
Countries
China
Contacts
China-Japan Friendship Hospital