Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB

UMIN ID: UMIN000001511

Registered date:20/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Dementia with Lewy bodies (DLB), Parkinson disease with dementia (PDD)
• Date of first enrollment: 2006/08/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Four weeks of conventional dose of YKS treatment

Outcome(s)

• Primary Outcome: Neuropsychiatric Inventry at baseline and after 2 and 4 weeks of YKS treatment.
• Secondary Outcome: MMSE, DAD, BEHAVE-AD, Zarit score, Fluctuation, biochemistry data at baseline and 4 weeks treatment

Key inclusion & exclusion criteria

• Age minimum: 55years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1.Malignancy 2.Severe life-thretning disease such as heart, liver, renal, blood diseases. 3.Other type of dementia i.e. Alzheimer disease, vascular dementia, FTD. 4.Neurodegenerative disease other than DLB or PD. 5.Other mental disorders such as depression, bipolardisorder,schizophrenia. 6.Hallucination due to alcohol abuse, drug abuse and / or other reasons 7. Use of neuroleptics (i.e. fluphenazine, haloperidol) within rescent 4 weeks. 8.Diagnosed as inadequate by the physician in charge

Related Information

• Primary Sponsor: yokukansan-DLB research group
• Source(s) of Monetary Support: Tsumura & Co.