UMIN-CTR Clinical Trial

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

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Basic information

Public title

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

Acronym

Yokukansan for DLB

Scientific Title

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

Scientific Title:Acronym

Yokukansan for DLB

Region

Japan


Condition

Condition

Dementia with Lewy bodies (DLB), Parkinson disease with dementia (PDD)

Classification by specialty

Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Neuropsychiatric Inventry at baseline and after 2 and 4 weeks of YKS treatment.

Key secondary outcomes

MMSE, DAD, BEHAVE-AD, Zarit score, Fluctuation, biochemistry data at baseline and 4 weeks treatment


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four weeks of conventional dose of YKS treatment

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

55 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion 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

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kosaka

Organization

Yokohama Hou-Yuu Hospital

Division name

psychiatry

Zip code


Address

Kanagaya Asahi-ku Yokohama City,Kanagawa,Japan

TEL

045-360-8787

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinji Ioka

Organization

Tsumura & Co.

Division name

Devision of medical research

Zip code


Address

2-17-11, Akasaka, Minato-ku Tokyo

TEL

03-6361-7185

Homepage URL


Email

ioka_shinji@mail.tsumura.co.jp


Sponsor or person

Institute

yokukansan-DLB research group

Institute

Department

Personal name



Funding Source

Organization

Tsumura & Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 11 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2006 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 08 Month 01 Day

Last follow-up date

2008 Year 12 Month 01 Day

Date of closure to data entry

2009 Year 01 Month 01 Day

Date trial data considered complete

2009 Year 03 Month 01 Day

Date analysis concluded

2009 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 11 Month 18 Day

Last modified on

2010 Year 02 Month 02 Day



Link to view the page

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