Insomnia
Conditions
Interventions
experimental group:Take half dose of Sini Powder at 8 : 00
take half dose of Sini Powder and full dose of Suanzaoren Decoction at 20 : 00.
control group:At 8 : 00 and 20 : 00, half dose of Sini Powder and Suanzaoren Decoction was taken respectively.
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ?. Aged between 18-65 years old, regardless of gender ; ?. In line with the diagnostic criteria of chronic insomnia in ICSD-3 and the diagnostic criteria of liver depression and blood deficiency syndrome in TCM clinical diagnosis and treatment terminology Part 2 : Syndrome ; ?. PSQI score between 8-15 points ; ?. The subjects volunteered to participate and signed informed consent.
Exclusion criteria
Exclusion criteria: ?. Secondary insomnia ( caused by or comorbid with moderate to severe depression or anxiety or acute stress events, etc. ) and other sleep disorders ( such as sleep apnea syndrome ) ; ?. Mental retardation can not cooperate with the completion of the questionnaire ; ?. Patients with liver, kidney, heart, brain, lung and other organic diseases ; ?. There are serious mental disorders, such as major depressive disorder, generalized anxiety disorder, etc. ; ?. HAMD = 17 points or HAMA = 14 points ; ?. Those who took antidepressants, anti-anxiety and other drugs in the past 2 weeks affected the efficacy evaluation. ; ?. Pregnant, lactating women or those with recent fertility requirements ; ?. Day and night shift workers, drug abuse and alcohol abuse patients ; ?. Allergic constitution or past allergies to any component of Sini Powder or Suanzaoren Decoction ; ?.Patients who participated in other clinical trials in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pittsburgh sleep quality index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia severity index scale;fatigue severity scale;fatigue self-assessment scale;epworth sleepiness scales;reduced Morningness-Eveningness Questionnaire ;the 12–items Short Form Health Survey;hamilton anxiety scale;hamilton depression rating scale;sleep monitoring;melatonin; ?-aminobutyric acid;5-hydroxyindoleacetic acid;brain-derived neurotrophic factor;chinese medicine syndrome scores;Constitutional changes of traditional Chinese medicine;Quantitative characteristics of traditional Chinese medicine tongue diagnosis;Quantitative characteristics of traditional Chinese medicine pulse diagnosis;Quantitative characteristics of traditional Chinese medicine face diagnosis; | — |
Countries
China
Contacts
Public ContactZhao Yonglie
The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine
Outcome results
None listed