UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of TJ-100 TSUMURA Daikenchuto extract granules for ethical use on abdominal bloating accompanied by constipation.
Title of the study (Brief title)	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	Mika Yuki
Organization	Izumo-city general medical center
Division name	Department of internal medicine
Address	613 Nadabun-cho, Izumo City, Shimane
TEL
Email

Public contact
Name of contact person
Organization	Izumo-city general medical center
Division name	Department of internal medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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