Primary insomnia
Conditions
Interventions
1:A Chinese herbal formula for 6 weeks
2:Placebo
Sponsors
Department of Psychiatry
Eligibility
Sex/Gender
Male
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male Chinese aged 65 or above; 2. Meet the diagnosis of primary insomnia according to DSM-IV; 3. Have insomnia for at least 4 weeks and more than 3 nights per week.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Participation in any other clinical trials within 30 days of visit 1; 2. With severe incapacitating medical illness, recent CVA, myocardial infraction within 6 months; 3. Any psychotic disorders, depressive disorders or anxiety disorders; 4. Intake of any benzodiazepines or other psychotropics within 1 month; 5. Current treatment with Chinese herbal medications; 6. Any disease state which, judged by the investigator, could interfere with study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective measurement by Actiwatch and subjective sleep recording (sleep questionnaire and sleep diary); | — |
Secondary
| Measure | Time frame |
|---|---|
| Global clinical impression, Hamilton depression and anxiety score, Epworth sleepiness scale, fatigue questionnaire, quality of life assessment, and general health questionnaire; | — |
Countries
China
Contacts
Public ContactMandy Yu
Outcome results
None listed