UMIN-CTR Clinical Trial

Basic information
Public title	Effect of daikenchuto for the decrease of colon diverticulum
Acronym	Effect of daikenchuto for the decrease of colon diverticulum
Scientific Title	Effect of daikenchuto for the decrease of colon diverticulum
Scientific Title:Acronym	Effect of daikenchuto for the decrease of colon diverticulum
Region	Japan

Condition
Condition	colon diverticulosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We stutdy that the effect of daikentyuto for the decrease of colon diverticulum
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The disappearance or decrease of colon diverticulum
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are 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	Daikenchuto
Interventions/Control_2	no treatment
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The one with a lower gut symptom among 20-year-old or more cases from whom the diverticulum of colon was admitted by the roentgenologic examination.
Key exclusion criteria	The patient who collides with either the following assumes that it doesn't put it in to the examination 1) Drug allergy
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Zip code
Address	3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL	045-787-2640
Email

Public contact
Name of contact person	1st name Middle name Last name Masahiko Inamori
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Zip code
Address	3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL	045-787-2640
Homepage URL
Email	inamorim@med.yokohama-cu.ac.jp

Sponsor
Institute	Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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	横浜市立大学附属病院（神奈川県）、たらお内科・消化器科（神奈川県）、横浜市立大学附属病院市民医療センター（神奈川県）、岐阜市民病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 08 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	2010 Year 12 Month 08 Day
Date of IRB	2011 Year 02 Month 01 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 12 Month 07 Day
Last modified on	2020 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005567