NIPH Clinical Trials Search

UMIN ID: UMIN000001511

Registered date:20/11/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedDementia with Lewy bodies (DLB), Parkinson disease with dementia (PDD)
Date of first enrollment2006/08/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Four weeks of conventional dose of YKS treatment


Primary OutcomeNeuropsychiatric Inventry at baseline and after 2 and 4 weeks of YKS treatment.
Secondary OutcomeMMSE, DAD, BEHAVE-AD, Zarit score, Fluctuation, biochemistry data at baseline and 4 weeks treatment

Key inclusion & exclusion criteria

Age minimum55years-old
Age maximum90years-old
GenderMale and Female
Include criteria
Exclude criteria1.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


public contact
Name Shinji Ioka
Address 2-17-11, Akasaka, Minato-ku Tokyo Japan
Telephone 03-6361-7185
Affiliation Tsumura & Co. Devision of medical research
scientific contact
Name Kenji Kosaka
Address Kanagaya Asahi-ku Yokohama City,Kanagawa,Japan Japan
Telephone 045-360-8787
Affiliation Yokohama Hou-Yuu Hospital psychiatry