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Trial registered on ANZCTR


Registration number
ACTRN12608000618358
Ethics application status
Approved
Date submitted
26/09/2008
Date registered
8/12/2008
Date last updated
9/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised placebo controlled clinical trial to study the therapeutic effectiveness of a Chinese herbal medicine formula used for the treatment of vascular dementia.
Scientific title
A randomised, double-blind, placebo controlled clinical trial to study the therapeutic effectiveness of a Chinese herbal medicine formula used for the treatment of vascular dementia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular dementia (VaD) 3757 0
Condition category
Condition code
Alternative and Complementary Medicine 3937 3937 0 0
Herbal remedies
Neurological 3938 3938 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine extract prepared in oral capsule form, with a dosage of three capsules daily for 16 weeks. The formulation ingredients remain commercial-in confidence.
Intervention code [1] 3471 0
Treatment: Drugs
Comparator / control treatment
The placebo will be prepared in an oral capsule extract designed to taste, smell and look the same as the active formulation, with a dosage of three capsules daily for 16 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4835 0
Measuring cognitive abilities using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) which is assessed by the trial researchers.
Timepoint [1] 4835 0
Baseline, weeks 8, 16, 32.
Secondary outcome [1] 8156 0
Measuring activities of daily living using the Alzheimer's Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL), which is administered by the trial researchers.
Timepoint [1] 8156 0
Baseline, weeks 8, 16, 32.
Secondary outcome [2] 8157 0
Measuring the overall health of the participant using the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), which is assessed by the trial researchers.
Timepoint [2] 8157 0
Baseline, weeks 8, 16, 32.
Secondary outcome [3] 8158 0
Measuring mental status using the Mini-Mental Status Examination (MMSE), which is administered by trial researchers.
Timepoint [3] 8158 0
Baseline, weeks 8, 16, 32.
Secondary outcome [4] 8159 0
Short Form Health Survey (SF-36) assessed by patients and researchers measuring physical and mental health.
Timepoint [4] 8159 0
Baseline, weeks 8, 16, 32.

Eligibility
Key inclusion criteria
1. A diagnosis of probable or possible Vascular Dementia (VaD) of more than or equal to 3 months in duration based on the NINDS-AIREN criteria.
2. Hichinski Ischemic Score (HIS) >4 to distinguish VaD from other types of dementia.
3. Absence of severe depression (Geriatric Depression Scale 15-item version, total score <11).
4. If patients have hypertension, diabetes, cardiac disease, or stroke, these disorders have been stable or controlled by medication for at least 3 months.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with other types of dementia, delirium, depression, schizophrenia, acute illness or poorly controlled chronic diseases.
2. Administration of drugs including: acetyl-cholinesterase inhibitors, ginko biloba, psychotropic drugs, hypnosedatives, antidepressants.
3.Significant liver or renal disease.
4. Severe dysphasia
5. Mental retardation
6. Life expectancy of <6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Geriatricians or psycho-geriatricians will assess the patients and classify them according to the National Institute of Neurological Disorders and Stroke (NINDS) and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) diagnostic criteria. Medical history and examination, blood tests for reversible dementia and neuropsychological assessment will be conducted if deemed necessary. Eligible patients will be randomly allocated to receive the active Chinese herbal medicine formulation or placebo. Medication randomisation is conducted by a computer at a central administration site where the trial medications are also labelled in numbered (coded) containers to maintain concealment for researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by computer. Patients and investigating staff will be blinded to treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3934 0
University
Name [1] 3934 0
University of Western Sydney
Address [1] 3934 0
Locked Bag 1797
Penrith South DC
NSW 1797
Country [1] 3934 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 3526 0
None
Name [1] 3526 0
Address [1] 3526 0
Country [1] 3526 0
Other collaborator category [1] 433 0
Hospital
Name [1] 433 0
Xi Yuan Hospital
Address [1] 433 0
No.1 Xi Yuan Cao Chang, Haidian District
Beijing
100091
Country [1] 433 0
China
Other collaborator category [2] 434 0
Hospital
Name [2] 434 0
Department of Aged Care & Rehabilitation, Bankstown Hospital
Address [2] 434 0
Locked Bag 1600
Bankstown
NSW 2200
Country [2] 434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5998 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 5998 0
Locked Bag 1797
Penrith South DC
NSW 1797
Ethics committee country [1] 5998 0
Australia
Date submitted for ethics approval [1] 5998 0
Approval date [1] 5998 0
09/09/2004
Ethics approval number [1] 5998 0
04/061
Ethics committee name [2] 5999 0
South Western Sydney Area Health Service
Ethics committee address [2] 5999 0
Locked Bag 7017
Liverpool BC
NSW 1871
Ethics committee country [2] 5999 0
Australia
Date submitted for ethics approval [2] 5999 0
Approval date [2] 5999 0
27/10/2004
Ethics approval number [2] 5999 0
04/057

Summary
Brief summary
Vascular dementia (VaD) is the second most common form of dementia and is a major cause of mental and physical disability in the elderly. There are currently no satisfactory or widely accepted medical options to help alleviate the symptoms associated with this disorder. Traditional Chinese medicine has a well-documented history of using herbal formulations for treatment of dementia-like disorders, but its therapeutic effectiveness has very little or no scientific validation. This controlled clinical trial will investigate the therapeutic effectiveness of a Chinese herbal medicine formula used in the treatment of VaD. 120 patients will be recruited to trial this formula over a four-month period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28981 0
Address 28981 0
Country 28981 0
Phone 28981 0
Fax 28981 0
Email 28981 0
Contact person for public queries
Name 12138 0
Centre for Complementary Medicine Research (CompleMED)
Address 12138 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 12138 0
Australia
Phone 12138 0
02 4620 3284
Fax 12138 0
Email 12138 0
complemed@uws.edu.au
Contact person for scientific queries
Name 3066 0
Centre for Complementary Medicine Research (CompleMED)
Address 3066 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 3066 0
Australia
Phone 3066 0
02 4620 3284
Fax 3066 0
Email 3066 0
complemed@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary