UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008070
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email yuuki-mika@izumo-hospital.jp

Sponsor
Institute Izumo-city general medical center
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.