?insomnia
Conditions
Interventions
Chinese medicine treatment group:Adopt the intervention of Compound Ciwujia Granules (1 bag/time, twice daily, days 1–28) combined with an Estazolam simulation tablet (1 mg/day, at bedtime, days 1–28)
?Western medicine control group:Adopt the regimen of Estazolam Tablets (1 mg/day, at bedtime, days 1–14) + Estazolam simulation tablets (1 mg/day, at bedtime, days 15–28) combined with Compound Ciwuji
Integrated traditional Chinese and Western medicine treatment group:The intervention consisted of Compound Ciwujia Granules (1 bag/time, twice daily, days 1–28) combined with Estazolam Tablets (1 mg/d
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 40 to 75 years, regardless of gender. (2) Able to read, comprehend, and follow the study procedures, and independently complete a sleep diary (3) Meet the diagnostic criteria for insomnia disorder as defined by the Chinese Sleep Research Society's "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2023)": self-reported sleep latency (SL) > 30 minutes and/or number of nocturnal awakenings = 2 times per night and/or self-reported total sleep time (TST) < 6.5 hours. Any of these three sleep disturbance symptoms must occur with a frequency of = 3 times per week, be accompanied by daytime dysfunction or distress, and persist for at least 3 months. (4) Meet the TCM pattern criteria for deficiency-type insomnia, specifically "Deficiency of the heart and spleen pattern" and "Qi deficiency of theheart and gallbladderpattem", as outlined in the "Integrated Traditional Chinese and Western Medicine Clinical Practice Guidelines for Insomnia Disorder (2023)". (5) A total score of = 8 on the Pittsburgh Sleep Quality Index (PSQI). (6) Volunteer to participate in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: (1) Patients with other sleep disorders, such as narcolepsy, sleep apnea syndrome, or those assessed as high-risk for Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS); (2) Patients with other mental disorders (e.g., obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder, etc.); (3) Subjects who are febrile (experiencing a fever); (4) Subjects with a Hamilton Depression Rating Scale 17-item (HAMD-17) total score = 17 or a Hamilton Anxiety Rating Scale (HAMA) total score = 14 at screening; (5) Individuals with a history of drug or alcohol dependence, addiction, or allergy to the investigational drug in this study; (6) Use of any hypnotic drugs, antipsychotic drugs, or other insomnia therapies within 1 week prior to the run-in period or within 5 half-lives of the drug (whichever is longer); (7) Presence of severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine (e.g., diabetes mellitus, hyperthyroidism), digestive (e.g., gastrointestinal obstruction, gastric and duodenal ulcers), hematopoietic (e.g., individuals with bleeding tendency), or other systemic diseases, or presence of laboratory test abnormalities: ALT or AST levels exceeding 1.5 times the upper limit of normal (ULN); Creatinine (Cr) level above the ULN; (8) Pregnant or lactating women; (9) Participants currently taking other investigational drugs, or whose washout period after stopping another clinical trial is less than 3 weeks; (10) Shift workers; (11) Other circumstances deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of improved sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of Sleep Function Recovery;Manifestations Across Various Dimensions of Sleep Quality;Improvement in Sleep-Related Depressive State;?Improvement in Sleep-Related Anxiety?;?Improvement in Sleep-Related Fatigue? ;Classification and Determination of Constitutions in Traditional Chinese Medicine ;Chinese medicine symptom complex score;Concomitant Medications for Sleep Disorders;Nocturnal continuous breathing, blood oxygen saturation, EEG waves and other indicators;Response rate (Proportion of subjects with a reduction of =50% in PSQI total score);Tongue manifestation, Pulse manifestation; | — |
Countries
China
Contacts
Public ContactChen Gang
?Hubei University of Chinese Medicine
Outcome results
None listed