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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000618358

Enrollment

120

Registered

2008-12-08

Start date

2004-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

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.

Outcome results