Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00085

2 Trial Registration Date

2005-10-03

i Registration Status

Retrospective

3 Secondary IDs

NA

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Department of Psychiatry

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Wing Yun Kwok

ii Address

Dept. of Psychiatry, 7/F Shatin Hospital

iii Phone

26367593

iv Email

Email ykwing@cuhk.edu.hk

v Affiliation

Dept. of Psychiatry, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Mandy Yu

ii Address

Dept. of Psychiatry, 7/F Shatin Hospital

iii Phone

2636-7593

iv Email

Email mandyyu@cuhk.edu.hk

v Affiliation

Dept. of Psychiatry, CUHK

vi Country

9 Official Scientific Title of the Study

Herbal treatment of primary insomnia in the elderly

10 Public Title

Herbal treatment of primary insomnia in the elderly

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-07-22

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Primary insomnia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

A Chinese herbal formula

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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

ii 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

iii Age Minimum

65

iv Age Maximum

NA

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-09-01

21 Target Sample Size

30

22 Recruitment Status

Complete

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-02-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2009-11-27