UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008070 |
|---|---|
| Receipt number | R000009507 |
| Scientific Title | Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation. |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2016/11/29 19:30:42 |
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Basic information
Public title
Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Acronym
Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Scientific Title
Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Scientific Title:Acronym
Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect information of efficacy and safety of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GSRS score
Key secondary outcomes
1)brease hydrogen
2)Nunber of bowel movements
3)Stool form and abdominal synptom
4)Abdominal fullness,overall evaluations(VAS)
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
Oral administration of Daikenchuto 1.5g/day in 2 or 3 divided doses before meals or between meales for 17days.
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 with abdominal bloating
2)Patients with constipation or who are diagnosed with constipation- predominant irritable bowel syndrome (Rome3 criteria)
3)Patients who can stop on-demand use of laxatives (Daily use is available)
4)Patients whose liver function measured in 6 months are less than the institutional upper limit of normal
5)Age: more than or equal to 20 years at the time of providing informed consent
6)Patients who can provide written informed consent
Key exclusion criteria
1)Patients with organic lesion such as inflammatory bowel disease (ulcerative colitis, Crohn disease) and cancer
2)Patients with signs of gastrointestinal obstruction or a history of total gastrectomy or colectomy but not appendicectomy
3)Patients who took Kampo medicines within 2 weeks
4)Patients who took antibiotics within 2 weeks
5)Patients who changed usage or adoministration of lactobacillus preparation, antacid, prokinetics, calcium polycarbophil, anticholinergics, laxatives, antidepressants, antianxiety drugs within 2 weeks
6)Patients with serious complications (liver, kidney, heart, circulatory, or metabolic disorder)
7)Patients who are lactating, pregnant or considering conception
8)Others, including patients who are unfit for the study as determined by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Yuki |
Organization
Izumo-city general medical center
Division name
Department of internal medicine
Zip code
Address
613 Nadabun-cho, Izumo City, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Izumo-city general medical center
Division name
Department of internal medicine
Zip code
Address
TEL
Homepage URL
yuuki-mika@izumo-hospital.jp
Sponsor or person
Institute
Izumo-city general medical center
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
出雲市立総合医療センター（島根県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 31 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009507
