Insomnia Disorder
Conditions
Interventions
control group:Zhenjing An Shen Fang placebo
Treatment group:Zhenjing Anshen Decoction
Sponsors
Wangjing Hospital Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18–65 years regardless of gender. (2) Patients meeting the diagnostic criteria for insomnia disorder in both traditional Chinese medicine (TCM) and Western medicine with a disease course =1 month and presenting with manifestations of liver depression transforming into fire syndrome. (3) Pittsburgh Sleep Quality Index (PSQI) score >7 [12]. (4) Insomnia Severity Index (ISI) score >7 and <22. (5) No language or intellectual impairment; able to comprehend scale content complete questionnaires voluntarily cooperate with the study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with secondary insomnia (insomnia disorder associated with or induced by other diseases) environmental sleep disorder obstructive sleep apnea syndrome (OSAS) or restless legs syndrome. (2) Shift workers i.e. individuals with inverted sleep-wake rhythms due to occupational requirements. (3) Patients with severe anxiety or depression (Hamilton Anxiety Scale score =21 Hamilton Depression Scale score =24). (4) Patients who have used other TCM or proprietary Chinese medicines for insomnia disorder non-short-acting sedative-hypnotics antidepressants or anxiolytics within 1 week prior to enrollment. (5) Patients with myasthenia gravis; acute exacerbation of chronic obstructive pulmonary disease (COPD); acute angle-closure glaucoma; or other severe primary cardiac hepatic pulmonary renal or hematologic diseases affecting survival. (6) Patients who are planning pregnancy pregnant or lactating. (7) Patients who have participated in other clinical trials within the past 3 months. (8) Patients with abnormal liver or kidney function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =1.5 times the upper limit of normal (ULN) or serum creatinine (Cr) >ULN. (9) Patients with a history of hypersensitivity (e.g. allergy to two or more drugs or foods) or known allergy to any component of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Scale-14;Hamilton's Anxiety Scale;Hamilton's Depression Scale;Insomnia Severity Index;Traditional Chinese Medicine (TCM) Syndrome Score Scale; | — |
Countries
China
Contacts
Public ContactLi hao
Wangjing Hospital Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed