UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.
Title of the study (Brief title)	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	Toru Kono
Organization	Sapporo Higashi Tokushukai Hospital
Division name	Center for Clinical and Biomedical Research
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	Toru Kono
Organization	Sapporo Higashi Tokushukai Hospital
Division name	Center for Clinical and Biomedical Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019145