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Trial History Detail on 2012-08-31

CUHK_CCT00009

2005-09-05

Retrospective

None

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

TANG Wai Kwong

NA

TANG Wai Kwong

email tangwk@cuhk.edu.hk

TANG Wai Kwong

email tangwk@cuhk.edu.hk

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

TCM in VaD

Yes

2005-03-01

Nervous System Diseases

Drug

Chinese Herb

12 weeks

Placebo

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.

Randomized

Placebo

Double-blind

Parallel

2005-04-01

60

Unknown

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

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)

No

2011-04-01

ChiCTR-TRC-09000622

2010-05-04


Yes

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