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Trial History Detail on 2015-02-23

CUHK_CCT00085

2005-10-03

Retrospective

NA

Institute of Chinese Medicine

Department of Psychiatry

NA

Wing Yun Kwok

Dept. of Psychiatry, 7/F Shatin Hospital

26367593

ykwing@cuhk.edu.hk

Dept. of Psychiatry, CUHK

Mandy Yu

Dept. of Psychiatry, 7/F Shatin Hospital

2636-7593

mandyyu@cuhk.edu.hk

Dept. of Psychiatry, CUHK

Herbal treatment of primary insomnia in the elderly

Herbal treatment of primary insomnia in the elderly

NA

Hong Kong

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

65

NA

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2004-09-01

30

Unknown

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

ChiCTR-TRC-05000667

2010-05-04


Yes

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