ACTRN12608000618358CompletedPhase 2
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.
niversity of Western Sydney0 sites120 target enrollmentStarted: December 8, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 60 Years to o limit (—)
- Sex
- All
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.
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.
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