UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030252 |
|---|---|
| Receipt number | R000034550 |
| 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. |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2021/01/13 17:38:32 |
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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
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
stratmagic@mac.com
Sponsor or person
Institute
Medical Corporation Seiaikai, Gion Usshita Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034550
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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