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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016531
Receipt No. R000019145
Scientific Title A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Date of disclosure of the study information 2015/02/13
Last modified on 2018/08/17

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Basic information
Public title A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Acronym A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Scientific Title A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Scientific Title:Acronym A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Region
Japan

Condition
Condition Ileostomy patients with abdominal bloating
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether daikenchuto is effective and safe in the treatment of abdominal bloating who has been ileostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Abdominal bloating
2)Gastrointestinal symptom rating scale(GSRS)
3)Analysis of ileostomy effluent
-intestinal flora
-organic acid
-pH
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Taking Daokenchuto 15g/day orally 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 has been ileostomy
2)Patients with abdominal bloating
3)Age: more than or equal to 20 years at the time of providing informed consent
4)Patients are male or female
5)Patients are in patients or out patients
6)Patients have ileotoma.
7)Provide written informed consent
Key exclusion criteria 1)Patients with strangulating intestinal obstruction.
2)Patients who are administrated preparation for viable organism within 4 weeks before this study.
3)Patients who was administrated daikenchuto or any Japanese traditional herbal medicine within 4 weeks before this study
4)Virus-positive (HIV, HBV, HCN)
5)Patients have serious coexisting disease (ex. Hepatic distorder, kidney disorder, cardiac disorder, hematological disorder, or metabolic disorder)
6)Women who was lactating or pregnant or person who hope the pregnancy of the partne.
7)Unsuitability as determined by the study doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kono
Organization Sapporo Higashi Tokushukai Hospital
Division name Center for Clinical and Biomedical Research
Zip code
Address 3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo
TEL 011-722-1110
Email kono@toru-kono.com

Public contact
Name of contact person
1st name
Middle name
Last name Toru Kono
Organization Sapporo Higashi Tokushukai Hospital
Division name Center for Clinical and Biomedical Research
Zip code
Address 3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo
TEL 011-722-1110
Homepage URL
Email kono@toru-kono.com

Sponsor
Institute Sapporo Higashi Tokushukai Hospital Center for Clinical and Biomedical Research
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
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
2015 Year 02 Month 13 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
2014 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 16 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
2015 Year 02 Month 13 Day
Last modified on
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019145

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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