Chronic Insomnia Disorder
Conditions
Interventions
Western medicine control group:Medication: Eszopiclone Tablets. Specification: 3mg/tablet * 7 tablets, manufactured by Chengdu Kanghong Pharmaceutical Group Co., Ltd. Dosage: 1.5mg per dose. Frequ
Traditional syndrome differentiation and treatment group:Basic Prescription: Soul-Soothing Sleep Decoction Ingredients: Ziziphi Spinosae Semen (Sour Jujube Seed) 20g, Schisandrae Chinensis Fructus (
AI-Assisted Decision-Making Group:The AI-assisted decision-making system for integrated Chinese and Western medicine clinical practice records TCM four diagnostic information, PSQI/SRSS/ISI scale scor
Sponsors
Sichuan integrative medicine hospital
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Aged 60-85 years, with symptoms persisting for over 3 months; 2) Meeting the diagnostic criteria for CID, accompanied by daytime dysfunction (e.g., fatigue, attention impairment, or mood dysregulation), and symptoms not attributable to other mental/physical disorders; 3) Pittsburgh Sleep Quality Index (PSQI) score = 8 and Insomnia Severity Index (ISI) score = 8; 4) Participation in this study must align with the individual's genuine willingness, comply with the clinical trial design, and involve personal signature on the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Age under 60 or over 85; 2) Sleep disorders with a clear cause (such as restless legs syndrome) or secondary insomnia caused by other diseases (hyperthyroidism, Parkinson's disease, etc.); 3) Comorbid severe mental disorders such as major depressive disorder, bipolar disorder, schizophrenia, Alzheimer's disease, or other cognitive impairments; 4) Accompanied by severe physical conditions such as cardiovascular or cerebrovascular diseases, liver or kidney dysfunction, or coagulation disorders; 5) Use of benzodiazepines, melatonin receptor agonists, or other medications or non-pharmacological treatments affecting sleep within the past month; 6) Insomnia caused by systemic conditions such as pain, fever, cough, surgery, trauma, or external environmental factors; 7) Allergy to eszopiclone or components of traditional Chinese medicine, pregnant or breastfeeding women, or patients who have participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index,PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index,ISI;the MOS item short fromhealth survey, SF-36;Clinical Symptom Scale for Insomnia in Traditional Chinese Medicine; | — |
Countries
China
Contacts
Public ContactZhou Hao
Sichuan integrative medicine hospital
Outcome results
None listed