UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Title of the study (Brief title)	Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Region	Japan

Condition
Condition	colonoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstration Shakuyaku-kanzo-to(TJ-68) and Minclea on the colonic wall by direct spraying
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Colonic wall movementis judgment to the score. After spraying medicine decreasing score is effective
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Shakuyaku-kanzo-to(TJ-68)5.0g+saline50ml
Interventions/Control_2	Minclea20ml
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	The patient agree with this study.
Key exclusion criteria	The patient is judgmented that unsuitable for this study. The patient has allergy to the medicine,primary aldosteronism,myopathy,hypokalemia,post operation of colon,inflammatory bowel diseases.
Target sample size	300

Research contact person
Name of lead principal investigator	Kazuki okamoto
Organization	Kinki University Hospital,Faculty of medichine
Division name	Gastroenterology
Address	377-2onohigashiosakasayamashiosakahu
TEL	072-366-0221
Email	hepa-gas@med.kindai.ac.jp

Public contact
Name of contact person	Kimiko Yuge
Organization	Gastroenterology
Division name	a medical office
Address	377-2onohigashiosakasayamashiosakahu
TEL	072-366-0221
Homepage URL
Email	kin-live@med.kindai.ac.jp

Sponsor
Institute	Kinki University Hospital,Faculty of medichine Gastroenterology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 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 10 Month 01 Day
Last modified on	2017 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022169