nonorganic insomnia
Conditions
Interventions
Treatment Group:fo shou ning shen granule
Placebo Group:?????????
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as nonorganic insomnia according to ICD-10 F 51.0 criteria; 2. the sleep latency period > 30 minutes, and/or, 2 or more awakening times at night, and/or total sleep time < 6 hours,present with the above complaint of sleep difficulties for more than 3 days during the last week,and for 1 or more months,3 months or less; 3. Fulfilment of the TCM insomnia diagnostic criteria; 4. Diagnosed as standard liver stagnation syndrome syndromes in TCM; 5. PSQI score 7 to 15 points; 6. Either gender aged 18-65 years; 7. Participation is voluntary and obtained through informed consent.
Exclusion criteria
Exclusion criteria: 1. secondary insomnia caused by systemic disease such as pain, fever, cough, surgery, etc., as well as lifestyle changes and external environmental disturbances; 2. patients with mixed affective disorder, schizophrenia and other severe mental disorders;the total crude score of a self-rating anxiety scale (SAS) = 40 (the standard score=50), and the total crude score of a self-rating depression scale (SDS)= 40 (the standard score=50); 3. Standardized treatment by any other drugs for insomnia within 1 month; 4. unstable diabetes mellitus and hyperthyroidism; 5. alcohol and/or psychoactive drug abusers and dependants; 6. serious diseases such as severe primary heart, liver, lung, kidney, blood disease or seriously affect the survival, such as tumor or abnormal liver and kidney function; 7. sleep apnea syndrome, paroxysm and other sleep disorders such as typical night terrors and nightmares; 8. diagnoses of epilepsy, COPD(chronic obstructive pulmonary disease), mental retardation, cognitive impairment, and restless legs syndrome; 9. allergic constitution, such as those of two or more drugs or food allergies; Or those who are known to be allergic to this drug; 10. pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Average subjective sleep latency;Subjective sleep duration;Number of subjective sleep awakenings;TCM syndrome integration; | — |
Countries
China
Contacts
Public ContactXie Wei
The TCM Institute of Southern Medical University
Outcome results
None listed