Insomnia
Conditions
Interventions
Experimental group:Zhouye Fentiao Formula
Control group:Zhouye Fentiao Formula Placebo
Sponsors
Xiyuan Hospital of CACMS
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Insomnia patients: (1) Participants aged 18–65 years (including boundary values), no gender restrictions; (2) Meet Western medical diagnostic criteria for insomnia; (3) PSQI total score >7 points; (4) Have not used long-acting sedative-hypnotic medications within the past month; (5) Understand the purpose of the study, be able to truthfully assess their own mental state, and voluntarily cooperate, sign an informed consent form, and voluntarily accept treatment in this study, with the informed consent process compliant with GCP regulations.
Exclusion criteria
Exclusion criteria: (1) Secondary insomnia and environmental sleep disorders caused by physical illnesses or symptoms of mental disorders; (2) Day-night rhythm reversal due to work-related reasons; (3) Patients taking medications containing components that affect sleep (such as olanzapine, clozapine, etc.) or taking psychiatric medications such as anti-anxiety or antidepressant drugs; (4) Patients with psychosis, severe anxiety disorders, or depression (patients with severe depression or anxiety on the Brief Depression-Anxiety-Stress Self-Rating Scale, with a score of =21 on the depression subscale and =15 on the anxiety subscale); (5) Cognitive impairments that prevent participants from understanding the study protocol, completing questionnaires, or providing informed consent, as well as poor adherence to medication schedules, poor compliance, or inability to maintain follow-up; (5) Cognitive impairments that prevent participants from understanding the trial instructions, completing questionnaires, or providing informed consent, as well as those who cannot adhere to the medication schedule, have poor compliance, or cannot maintain follow-up; (6) Alcohol addiction or dependence on psychotropic medications; (7) Concurrent severe cardiovascular, respiratory, or other systemic diseases, malignant tumors, or neurological disorders, or a history of severe head trauma. Abnormal liver or kidney function (AST, ALT > 1.5 times the upper limit of the normal reference range, SCr exceeding the upper limit of the normal range), or clinically significant ECG abnormalities; (8) Patients with diabetes and poor glycemic control; (9) Pregnant or breastfeeding women; (10) Patients who have participated in other clinical trials within the past month; (11) Patients with known allergies to certain drugs or items used in this study's medications and interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14;Epworth Sleepiness Scale;Depression-Anxiety-Stress Scale; | — |
Countries
China
Contacts
Public ContactZhu Zhengchuan
Xiyuan Hospital of CACMS
Outcome results
None listed