UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Acronym	The efficacy of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Scientific Title	The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Scientific Title:Acronym	The efficacy of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Region	Japan

Condition
Condition	Abdominal pain and abdominal fullness feeling in the patients with fecal incontinence
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of Daikenchuto on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Numeric Rating Scale (NRS) of abdominal pain 2) NRS of abdominal fullness feeling
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Daikenchuto (15g/day) for 4 weeks
Interventions/Control_2
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	1)Patients who have faecal incontinence of 2-4 times/4 weeks or more in the past 6 months 2)Patients who have abdominal pain or abdominal fullness feeling 3)Age: Aged 20 and over 4)Mini Mental State Examination (MMSE)>=11 5)Patients for whom oral administration was possible 6)Patients who provided written informed consent regarding study participation.
Key exclusion criteria	1)Patients who have anal sphincter injury 2)Patients who have severe mental illness 3)Patients who can not perform their daily activities 4)Suspected organic disease such as the cancer in gastrointestinal tract 5)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease) 6)Patients who took drugs prohibited for concomitant use 2 weeks before entry. 7)History of allergic reactions to Kampo medicines 8)Pregnant or lactating women or those who are planning to conceive during the study period 9)Considered ineligible to participate by principal investigator or sub-investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazufumi Middle name Last name Shimazutsu
Organization	Medical Corporation Seiaikai, Gion Ushita Hospital
Division name	Gion Ushita Hospital
Zip code	731-0113
Address	8-29-24 nishihara, asa minami-ku, hiroshima
TEL	082-850-3116
Email	stratmagic@mac.com

Public contact
Name of contact person	1st name Kazufumi Middle name Last name Shimazutsu
Organization	Medical Corporation Seiaikai, Gion Ushita Hospital
Division name	Gion Ushita Hospital
Zip code	731-0113
Address	8-29-24 nishihara, asa minami-ku, hirosima
TEL	082-850-3116
Homepage URL
Email	stratmagic@mac.com

Sponsor
Institute	Medical Corporation Seiaikai, Gion Usshita Hospital
Institute
Department

Funding Source
Organization	Tsumura & Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University Certified Review Board
Address	1-2-3, Kasumi, MInami-ku, Hiroshima City
Tel	082-257-1551
Email	iryo-seisaku@office.hiroshima-u.ac.jp

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	ぎおん牛田病院（広島県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 11 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	2017 Year 12 Month 01 Day
Date of IRB	2020 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 11 Day
Last follow-up date	2019 Year 03 Month 04 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 12 Month 04 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034550