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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027976
Receipt No. R000031487
Scientific Title Evaluation of the efficacy of yokukansan for postoperative delirium
Date of disclosure of the study information 2017/07/03
Last modified on 2019/06/14

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Basic information
Public title Evaluation of the efficacy of yokukansan for postoperative delirium
Acronym Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title:Acronym Evaluation of the efficacy of yokukansan for postoperative delirium
Region
Japan

Condition
Condition postoperative delirium
Classification by specialty
Psychosomatic Internal Medicine Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of yokukansan as preventive internal administration for post operative delirium
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence rate of delirium diagnosed using DSM-5 by psychiatrists on postoperative day 1,2, and 3
Key secondary outcomes Severity of delirium by Delirium Rating Scale R-98
Safety (adverse events, laboratory values, postoperative complications, postoperative mortality)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Yokukansan group take 2.5 g of yokukansan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking yokukansan as soon as possible and take until the 3rd postoperative day.
Interventions/Control_2 Control group take 2.5 g of anchusan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking anchusan as soon as possible and take until the 3rd postoperative 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 Patients who need surgery for gastrointestinal cancerPatients who can start oral administration early after surgery
Key exclusion criteria Patients with past history of hypersensitivity to yokukansan or anchusan
Patients diagnosed with pseudoaldosteronism
Patients diagnosed with heart failure
Patients with a history of rhabdomyolysis
Patients diagnosed with interstitial pneumonia
Patients diagnosed with liver failure
Patients who cannot start oral administration early after surgery, such as esophageal cancer patients
Patients with mood disorder, schizophrenia, schizoaffective disorder, alcoholism, drug addiction
Patients determined to be unable to join the clinical trial
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Fujiwara
Organization Tottori University Hospital
Division name Gastrointestinal surgery
Zip code
Address 36-1 Nishi-cho Yonago-shi
TEL 0859-38-6567
Email y-fujiwara@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akimitsu Tanio
Organization Tottori University Hospital
Division name Gastrointestinal surgery
Zip code
Address 36-1 Nishi-cho Yonago-shi
TEL 0859-38-6567
Homepage URL
Email atanio@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization Tottori University Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 03 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
2017 Year 05 Month 22 Day
Date of IRB
2017 Year 04 Month 25 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031487

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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