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Trial History Detail on 2011-02-08

CUHK_CCT00087

2005-10-12

Prospective

NA

N/A

Hong Kong Consortium for Globalization of Chinese Medicine

NA

Wing Yun Kwok

Dept. of Psychiatry, 7/F Shatin Hospital

2636-7593

Email ykwing@cuhk.edu.hk

Dept. of Psychiatry, CUHK

Mandy Yu

Dept. of Psychiatry, 7/F Shatin Hospital

2636-7593

Email mandyyu@cuhk.edu.hk

Dept. of Psychiatry, CUHK

Clinical Trial on Herbal Treatment of Primary Insomnia – a randomized placebo-controlled study

Clinical Trial on Herbal Treatment of Primary Insomnia – a randomized placebo-controlled study

NA

Hong Kong

Yes

2005-10-04

Primary insomnia

Drug

A Chinese herbal formula

4 weeks

Placebo

Inclusion criteria: 1. Chinese aged 18-65 2. Meet the diagnosis of primary insomnia

Exclusion criteria: 1. Participation in other clinical trial within 30 days of the first visit 2. With severe incapacitating medical illnesses, recent CVA, myocardinal infarction within 6 months 3. Any psychiatric disorders 4. Pregnancy 5. Intake of any benzodiazepines or other psychotropics during the 2 weeks period prior to entry 6. Current treatment with Chinese herbal medication 7. Any disease state which, judged by the investigator, could interfere with study evaluation

18

65

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2006-01-01

200

Complete

Subjective sleep recording (sleep log, fatigue questionnaire, sleep symptoms), Objective measurement (Actiwatch, polysomnography)

Clinical global impression, psychiatric assessment (SCID, HADS, BDI)

No

2013-01-10

ChiCTR-TRC-09000668

2010-05-04


Yes

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