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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031475
Receipt No. R000035929
Scientific Title The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Date of disclosure of the study information 2018/03/01
Last modified on 2020/09/08

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Basic information
Public title The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Acronym The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Scientific Title The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Scientific Title:Acronym The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Region
Japan

Condition
Condition defecation disorders
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the improvement effect of daikenchuto on the abdominal discomfort (pain) in patients with defecation disorders by using Constipation Scoring System (CSS) etc.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in score of CSS (Constipation Scoring System) before and after administration of daikenchuto
Key secondary outcomes 1. Change in score of CCIS (Cleveland Clinic Incontinence Score) before and after administration of daikenchuto
2. Change in anal pressure before and after administration of daikenchuto
3. To explore the influencing factors on change in CSS, CCIS and anal pressure before and after administration of daikenchuto

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016
2. Patient with defecation disorder
Key exclusion criteria Patient without abdominal discomfort (pain) before proceeding to be dosed
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Abe
Organization Kunimoto Hospital
Division name Department of Proctology
Zip code 070-0061
Address 1-7-2-1 Akebono, Asahikawa, Hokkaido
TEL 0166-25-2241
Email t-abe@cf6.so-net.ne.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Abe
Organization Kunimoto Hospital
Division name Department of Proctology
Zip code 070-0061
Address 1-7-2-1 Akebono, Asahikawa, Hokkaido
TEL 0166-25-2241
Homepage URL
Email t-abe@cf6.so-net.ne.jp

Sponsor
Institute Kunimoto Hospital
Institute
Department

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

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

IRB Contact (For public release)
Organization IRB of the Maebashi Hirosegawa Clinic
Address 2-10-9 Chiyotamachi Maebashi-shi Gunma
Tel 027-231-4101
Email kaneko@smo-msr.co.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 医療法人健康会くにもと病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_file_dl.cgi?recptno=R000035929&file_id=00001&file_kind=1
Publication of results Published

Result
URL related to results and publications https://doi.org/10.23922/jarc.2019-012
Number of participants that the trial has enrolled 157
Results
On the CCIS, total score was significantly improved after administration of DKT. On the CSS, no significant difference was found in the total score. On the Bristol Stool Form Scale, DKT showed a tendency to normalize stool consistency. Maximum resting anal pressure and maximum squeeze anal pressure significantly increased after the administration of DKT. No side effects caused by DKT were observed during the study. 
Results date posted
2020 Year 09 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 157 patients who fulfilled the appropriate criteria within the study period were enrolled. Their mean age was 73.6 years old, and female patients accounted for 75%.
The type of FI was passive incontinence in 86 cases, urge incontinence in 8 cases, and passive and urge incontinence in 63 cases.
Of the subjects of this study, 45 had already used laxatives.
Participant flow
Patients who visited the hospital from January 2012 to December 2016 due to FI as the major complaint and were treated with DKT were included as study participants. Patients with organic disorders of the rectoanal region, such as rectal prolapse, abscess, and tumor, or who used treatment other than DKT were excluded.
As this is a retrospective observational research using existing data collected by the hospital, the written consent was not obtained from the patients in advance. Therefore, the contents of the research were posted in the hospital to inform the subjects, providing the opportunity to refuse the usage of their data in the research.
Adverse events
No side effects caused by DKT were observed during the study period.
Outcome measures
Clevaland Clinic Incontinence Score
Constipation Scoring System
Bristol Stool Form Scale
Maximum resting anal pressure
Maximum squeeze anal pressure 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 01 Month 09 Day
Date of IRB
2018 Year 01 Month 24 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2018 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study of patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016

Management information
Registered date
2018 Year 02 Month 26 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035929

Research Plan
Registered date File name
2020/09/08 UMIN000031475_protocol.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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