Insomnia
Conditions
Interventions
Healthy peaple:None
Insomnia :None
Effective Chinese Medicine Treatment Group:Received standardized TCM treatment
Sponsors
Jiangsu Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years, male or female; 2. Meeting the diagnostic criteria for chronic insomnia disorder; 3. Main syndromes: heat sensation in the body, restlessness and irritability, red tongue with yellow and greasy coating; 4. Received Chinese medicine treatment for more than 1 month with significant improvement; 5. Provided informed consent and voluntarily participated in this study.
Exclusion criteria
Exclusion criteria: 1. Insomnia caused by sleep apnea syndrome or somatic diseases; 2. Severe depression with suicidal ideation or a history of suicidal behavior; 3. Main syndromes: subjective aversion to cold, pale tongue with thin white coating; 4. Pregnant or lactating women; 5. Severe primary diseases of the heart, liver, lung, kidney, or hematological system, or other life-threatening severe diseases (e.g., malignant tumor, AIDS); serum creatinine (SCr) > 1.5 × upper limit of normal (N), alanine aminotransferase (ALT) > 2 × N, white blood cell (WBC) count < 3.0 × 10?/L; 6. Individuals unable to provide adequate informed consent due to mental disorders; 7. Other conditions deemed unsuitable for enrollment by the investigator, such as those prone to loss to follow-up due to environmental changes; 8. Individuals currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequencing of gut microbiota;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire?9;Inflammatory factors;Melatonin; | — |
Countries
China
Contacts
Public ContactXiuqin Wang
iangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed