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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023031
Receipt No. R000026542
Scientific Title A prospective randomized control trial of effect of castor oil for colon capsule endoscopy excretion rate.
Date of disclosure of the study information 2016/07/16
Last modified on 2016/07/15

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Basic information
Public title A prospective randomized control trial of effect of castor oil for colon capsule endoscopy excretion rate.
Acronym Castor trial
Scientific Title A prospective randomized control trial of effect of castor oil for colon capsule endoscopy excretion rate.
Scientific Title:Acronym Castor trial
Region
Japan

Condition
Condition colorectal diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to make influence of castor oil on colon capsule endoscopy excretion rate clear.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes colon capsule endoscopy excretion rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 to use castor oil
Interventions/Control_2 not to use castor oil
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients of adaptation on colon capsule endoscopy
Key exclusion criteria contraindication to colon capsule endoscopy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanao Nakamura
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2172
Email makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Sato
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2172
Homepage URL
Email satoh11@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University 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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 16 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 05 Day
Last modified on
2016 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026542

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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