Chronic insomnia
Conditions
Interventions
Treatment group:Yishen Yangxin Anshen Tablets, 4 tablets per dose, 3 times daily.
Control Group:Conventional treatment
Sponsors
Shijiazhuang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 or above, regardless of gender; (2) Meeting the diagnostic criteria for heart-blood deficiency and kidney-essence insufficiency syndromes in traditional Chinese medicine according to the Guidelines for Clinical Research of New Traditional Chinese Medicine; (3) Meeting the diagnostic criteria for insomnia disorder as defined in the International Classification of Sleep Disorders (Third Edition) (ICSD-3); (4) Pittsburgh Sleep Quality Index (PSQI) score = 7; (5) Insomnia Severity Index (ISI) score = 8; (6) Voluntary participation in this study, with a signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Self-reported history of systemic diseases such as pain, fever, cough, surgery; or other conditions affecting sleep: narcolepsy, circadian rhythm sleep disorders, sleepwalking, sleep-related breathing disorders, obstructive or central sleep apnea syndrome, restless legs syndrome, etc., as well as insomnia caused by external environmental disturbances. (2) Self-reported history of insomnia caused by schizophrenia, depression, anxiety, or other mental disorders. (3) Self-reported history of insomnia caused by certain somatic diseases, brain organic diseases, brain injury syndrome, or drug reactions. (4) Self-reported history of poor sleep hygiene, jet lag syndrome, shift work, or irregular schedules leading to sleep disorders; sleep apnea syndrome, narcolepsy, or other sleep disorders such as night terrors or nightmares causing insomnia. (5) Concurrent liver function impairment, with ALT or AST = 2 times the upper limit of normal. (6) Allergic constitution, pregnancy, preparation for pregnancy, or breastfeeding. (7) Participation in other drug clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale;PSQI single-item factor;Traditional Chinese Medicine Syndrome Scoring; | — |
Countries
China
Contacts
Public ContactZhang Shuyuan, Yuan Kun
Shijiazhuang Hospital of Traditional Chinese Medicine
Outcome results
None listed