Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00009

2 Trial Registration Date

2005-09-05

i Registration Status

Retrospective

3 Secondary IDs

None

4 Source(s) of Funding

The Institute of Chinese Medicine of the Chinese University of Hong Kong.

5 Primary Sponsor

TANG Wai Kwong

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

TANG Wai Kwong

ii Address

iii Phone

tangwk@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

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

i Name

TANG Wai Kwong

ii Address

iii Phone

tangwk@cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

A pilot study on the safety and efficacy of a Traditional Chinese Medicine Formula in Vascular Dementia.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

TCM in VaD

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-03-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Nervous System Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Chinese Herb

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 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.age of 40-90 2.NINDS-AIREN-defined probable or possible VaD (Roman et al., 1993) 3.Mini-Mental State Examination (MMSE) (Chiu et al., 1994) score ranging from 10 to 25. 4.Absence of expectation of premature withdrawal, and insufficient compliance to the treatment and assessment regime. 5.Available informant. Exclusion criteria. 1. History of intracerebral haemorrhage or other bleeding tendencies. 2.Concurrent warfarin treatment or abnormal clotting profile. 3.The patient is within a 2-week postoperative period of any major surgery or there is a scheduled surgery within 2 weeks after the study period. 4.Concurrent consumption of the following herbs, which may increase the risk of bleeding: feverfew, garlic, ginseng, dong quai, red clover, and other natural coumarins. 5.Known hypersensitivity to any of the five ingredients of the herb. 6.Concurrent significant medical conditions including life threatening cardiac or pulmonary diseases, liver disease or chronic renal insufficiency.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

2005-04-01

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) The Clinician Interview-Based Impression rating scale (Knopman et al., 1994).

24 Secondary Outcome

Mini-Mental State Examination. Sum of Boxes Clinical Dementia Rating. (Berg, 1988)Frontal Assessment Battery (FAB; Mok, 2004) Modified Fuld Verbal Fluency Test (VFT; Chiu et al., 1997)Stroop Test (Stroop, 1992)15-items Chinese version of the Geriatric Depression Scale (Lim et al., 2000) Instrumental Activities of Daily Living scale (Tony & Man, 2002). Neuropsychiatric Inventory (Leung et al., 2001)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

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 2009-10-20