UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004417
Receipt number R000005151
Scientific Title Examination of efficacy of yokukansan for postoperative delirium.
Date of disclosure of the study information 2010/10/25
Last modified on 2015/04/21 07:20:49

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Basic information

Public title

Examination of efficacy of yokukansan for postoperative delirium.

Acronym

Examination of efficacy of yokukansan for postoperative delirium.

Scientific Title

Examination of efficacy of yokukansan for postoperative delirium.

Scientific Title:Acronym

Examination of efficacy of yokukansan for postoperative delirium.

Region

Japan


Condition

Condition

postoperative delirium

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination the effect of reducing the incidence of postoperative delirium by perioperative administration of yokukansan for eiderly patients with gastrointestinal cancer surgery at risk of postoperative delirium.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

CAM

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

yokukansan peroral administration, 7.5g/day, 3 times/day

Interventions/Control_2

none

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients over 75 years
2) There is no gender specification
3) Patients who have signed consent to participate in this research.

Key exclusion criteria

1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases
2) eurodegenerative disease, schizophrenia, bipolar disorder
3) Alcohol abuse, drug abuse
4) Patients who are otherwise classified as unfit by the attending physicians for the research.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Suzuki

Organization

Nippon Medical School Musashi Kosugi
Hospital

Division name

Digestive Disease Center

Zip code


Address

1-396 Kosugi,Kawasaki,kanagawa 211-8533 JAPAN

TEL

044-733-5181

Email

hide2808@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Nomura

Organization

Nippon Medical School Musashi Kosugi

Division name

Digestive Disease Center

Zip code


Address

1-396 Kosugi,Kawasaki,kanagawa 211-8533 JAPAN

TEL

044-733-5181

Homepage URL


Email

carlos10valderrama@yahoo.co.jp


Sponsor or person

Institute

Nippon Medical School Musashi Kosugi
Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kanto Rosai hospital
Kawasaki Saiwai hospital
Teikyo University School Medicine Uniersity Hospital Mizonokuchi
Omori Red Cross Hospital
Kawasaki Municipal Hospital

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

2010 Year 10 Month 25 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

Open public recruiting

Date of protocol fixation

2010 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2014 Year 05 Month 01 Day

Date of closure to data entry

2014 Year 05 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 10 Month 20 Day

Last modified on

2015 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005151


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name