UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016531 |
|---|---|
| Receipt number | 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 10:14:45 |
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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
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
kono@toru-kono.com
Sponsor or person
Institute
Sapporo Higashi Tokushukai Hospital Center for Clinical and Biomedical Research
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019145
