Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00087

2 Trial Registration Date

2005-10-12

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

N/A

5 Primary Sponsor

Hong Kong Consortium for Globalization of Chinese Medicine

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

2636-7593

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

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

10 Public Title

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

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?

2005-10-04

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

4 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. Chinese aged 18-65 2. Meet the diagnosis of primary insomnia

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

65

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

2006-01-01

21 Target Sample Size

200

22 Recruitment Status

Complete

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-10

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000668

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2011-02-08