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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013235
Receipt No. R000015379
Scientific Title An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.
Date of disclosure of the study information 2014/02/26
Last modified on 2018/09/18

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Basic information
Public title An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.
Acronym A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.
Scientific Title An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.
Scientific Title:Acronym A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.
Region
Japan

Condition
Condition Digestive system cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the inhibition effect and safety of yokukansan for onset of postoperative delirium in elderly.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative delirium
Key secondary outcomes Postoperative length of stay in the hospital
Severity of symptoms of delirium
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 yokukansan administering group(7.5mg/day)
Interventions/Control_2 yokukansan non-administering group (0mg/day)
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 who scheduled surgical resection of malignant tumor of digestive system.
2) Patients who can be administered drugs orally.
3) Patients who give written informed consent to participate in the study
Key exclusion criteria 1) Patients who require emergency surgery.
2)Patients with severe complications, including cardiac, renal, blood or lung diseases, or with other complications judged to be life-threatening.
3)Patients administered antipsychotic agents and therapeutic agents for dementia.
4)Patients administered Kampo medicines other than the study drug.
5) Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsunehiko Maruyama
Organization Hitachi,Ltd.,Hitachi General Hospital
Division name Surgery
Zip code
Address 2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL 0294-23-1111
Email tsunehiko.maruyama.kq@hitachi.com

Public contact
Name of contact person
1st name
Middle name
Last name Masayo Okawa
Organization Hitachi,Ltd.,Hitachi General Hospital
Division name clinical research center
Zip code
Address 2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL 0294-23-1111
Homepage URL
Email masayo.okawa.ne@hitachi.com

Sponsor
Institute Hitachi,Ltd.,Hitachi General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 株式会社日立製作所 日立総合病院(茨城県)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 26 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 Terminated
Date of protocol fixation
2013 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015379

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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