Chronic insomnia disorder in adults
Conditions
Interventions
Treatment Group:Suanzaoren decoction granule plus Zolpidem Tartrate tablet placebo
Control Group:Zolpidem Tartrate tablet plus Suanzaoren decoction granule placebo
Placebo Group:Zolpidem Tartrate tablet placebo plus Suanzaoren decoction granule placebo
Sponsors
Department of Neurology, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-80 years old; 2) Chronic insomnia disorder diagnosed by two clinical attending doctors according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) criteria; 3) after a shared decision-making, clinicians decide to add pharmacological therapy while the cognitive and bahaviour therapy for insomnia (CBT-I) alone is unsuccessful; 4) has good compliance and willing to accept the test; 5) No mental disease or using psychoactive medications; 6) Signed the written informed consent form for the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Diagnoses of severe hepatic, renal or thyroid dysfunction or cardiovascular diseases; 2) Has a severe psychiatric disorder or a history of major psychiatric disorder (for example, depression, anxiety, autism, schizophrenia and so on); 3) Diagnoses of other sleep disorders (such as narcolepsy, obstructive sleep apnea syndrome or restless legs syndrome); 4) Taking medications, psychotherapy or acupuncture for insomnia within a month; 5) Taking part in other clinical trial; 6) Diagnosed with severe, life-threatening chronic sleep disorders; 7) Not suitable for the study by a physician's evaluation; 8) Pregnancy, breast-feeding or juvenile.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Sleep Diary; | — |
Countries
China
Contacts
Public ContactZheng Guo-qing/Yan Lin
Department of Neurology, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Outcome results
None listed