A randomised placebo controlled clinical trial to study the therapeutic effectiveness of a Chinese herbal medicine formula used for the treatment of vascular dementia.

Phase 2

Completed

• Conditions: Vascular dementia (VaD); Alternative and Complementary Medicine - Herbal remedies; Neurological - Dementias

• Registration Number: ACTRN12608000618358
• Lead Sponsor: niversity of Western Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified