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Trial History Detail on 2005-10-03

CUHK_CCT00085

2005-10-03

Retrospective

Institute of Chinese Medicine

Department of Psychiatry

Wing Yun Kwok

ykwing@cuhk.edu.hk

Email

Mandy Yu

mandyyu@cuhk.edu.hk

Email

Herbal treatment of primary insomnia in the elderly

Yes

2004-07-22

Primary insomnia

Drug

A Chinese herbal formula

6 weeks

Placebo

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: 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

Randomized

Placebo

Double-blind

Parallel

2004-09-01

30

Recruiting

Objective measurement by Actiwatch and subjective sleep recording (sleep questionnaire and sleep diary)

Global clinical impression, Hamilton depression and anxiety score, Epworth sleepiness scale, fatigue questionnaire, quality of life assessment, and general health questionnaire

No

2015-02-23


Yes

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