Chronic insomnia
Conditions
Interventions
High-dose group:Jiaobai Anshen Granules, 2 packets, take with warm water, 3 times a day, for an 8-week course.
Low-dose group:Zao Bai An Shen Granules 1 packet + Zao Bai An Shen Granules placebo 1 packet, take with warm water, 3 times a day, for an 8-week course
Placebo group:Zao Bo An Shen Granules Simulated Agent 2 packets, taken with warm water, 3 times daily, for an 8-week course.
Sponsors
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for chronic insomnia. 2. Meets the TCM diagnostic criteria for deficiency of liver blood and internal disturbance by (xu re). 3. Age between 18 and 65 years old (inclusive). 4. Has not used any medications for the treatment of insomnia during the week prior to the run-in period and throughout the run-in period. 5. Pittsburgh Sleep Quality Index (PSQI) total score >7, and average number of insomnia days per week during the run-in period =3 days. 6. Able to cooperate and independently complete the evaluation and recording of questionnaires. 7. Able to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient must currently take sleep aids or health supplements on a regular basis; 2. Patients with systemic diseases such as pain, fever, cough, surgery, or insomnia caused by external environmental interference factors; 3. Patients with a history of other conditions affecting sleep: narcolepsy, circadian rhythm sleep disorders, sleepwalking, sleep-related breathing disorders, obstructive or central sleep apnea syndrome, etc.; 4. Patients previously diagnosed with schizophrenia, anxiety, depression, or other severe mental disorders; or with a family history of mental illness; 5. Patients previously diagnosed with severe cardiovascular, pulmonary, hepatic, renal, endocrine, or central nervous system diseases, or malignant tumors; 6. Patients with a history of hypertension that remains uncontrolled despite antihypertensive treatment (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); 7. Patients with suspected or confirmed history of alcohol or substance abuse or dependence; 8. Pregnant, breastfeeding women, or women planning pregnancy within the next 3 months, and their partners; 9. Patients who have or are expected to have shift work involving day and night changes within 8 weeks after randomization during the run-in period; 10. Patients with a known allergy to the investigational drug or its components; 11. Patients who previously developed liver dysfunction after using formulations containing *Caulis Polygoni Multiflori* (); 12. Patients with a Hamilton Anxiety Scale score =14 or a Hamilton Depression Scale score =17 at screening; 13. Patients with elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) above the upper limit of normal; 14. Patients who have participated in or are currently participating in another clinical trial within 1 month prior to randomization; 15. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a cumulative score =7 points across the 7 components of the Pittsburgh Sleep Quality Index (PSQI).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with improvement in cumulative scores of the 7-factor components of the Pittsburgh Sleep Quality Index.;Sleep Quality Improvement;Insomnia Severity Index;Evaluation of Daytime Functioning in the Insomnia Severity Index;Change in TCM Syndrome Score and Efficacy Rate;Sleep Diary;Polysomnography;Usage of hypnotic medications; | — |
Countries
China
Contacts
Public ContactWu Minghua
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed