Unique ID issued by UMIN | UMIN000001511 |
---|---|
Receipt number | R000001811 |
Scientific Title | Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB |
Date of disclosure of the study information | 2008/11/20 |
Last modified on | 2010/02/02 10:49:40 |
Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB
Yokukansan for DLB
Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB
Yokukansan for DLB
Japan |
Dementia with Lewy bodies (DLB), Parkinson disease with dementia (PDD)
Geriatrics | Psychiatry |
Others
NO
To investigate the effects and safety of yokukansan (YKS) for behavioral and psychological symptoms of dementia with Lewy bodies (DLB), and Parkinson deseiase with dementia (PDD).
Safety,Efficacy
Confirmatory
Explanatory
Phase III
Neuropsychiatric Inventry at baseline and after 2 and 4 weeks of YKS treatment.
MMSE, DAD, BEHAVE-AD, Zarit score, Fluctuation, biochemistry data at baseline and 4 weeks treatment
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Uncontrolled
1
Treatment
Medicine |
Four weeks of conventional dose of YKS treatment
55 | years-old | <= |
90 | years-old | > |
Male and Female
1.Probable DLB patients diagnosed according to the international consensus criteria for DLB. Parkinson's disease (PD) with dementia is also included.
2.Patients with 4 or more points at least one subscale of NPI
3.Serum potessium is within normal limit.
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
60
1st name | |
Middle name | |
Last name | Kenji Kosaka |
Yokohama Hou-Yuu Hospital
psychiatry
Kanagaya Asahi-ku Yokohama City,Kanagawa,Japan
045-360-8787
1st name | |
Middle name | |
Last name | Shinji Ioka |
Tsumura & Co.
Devision of medical research
2-17-11, Akasaka, Minato-ku Tokyo
03-6361-7185
ioka_shinji@mail.tsumura.co.jp
yokukansan-DLB research group
Tsumura & Co.
Profit organization
Japan
NO
2008 | Year | 11 | Month | 20 | Day |
Unpublished
Completed
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 08 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 01 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2008 | Year | 11 | Month | 18 | Day |
2010 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001811
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |