UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The antispasmodic effective of shakuyaku-kanzo-to(TJ-68) on the colonic wall by direct spraying:a randomized controlled prospective study
Title of the study (Brief title)	Shakuyaku-kanzo-to(TJ-68) for the colonoscopy
Region	Japan

Condition
Condition	The over twenty years old patient perform the large intestine endoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The efficacy of the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine after three minute late
Key secondary outcomes	The background of patient and the time of the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	shakuyaku-kanzoutou 5.0g in the 50ml saline of 36celsius
Interventions/Control_2	the 50ml saline of 36celsius
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 pacient of performed the colonoscopy
Key exclusion criteria	the pacient has the allergy of shakuyaku-kannzoutou. the pacient has the aldosteronism. the pacient has the myopathy. the pacient has the hypokalemia. the pacient of post operation. tha pacient has IBD.
Target sample size	70

Research contact person
Name of lead principal investigator	Kazuki okamoto
Organization	Kinki University School of Medicine
Division name	Department of gastroenterology and Hepatology
Address	377-2onohigashi osakasayama-shi osaka-hu
TEL	072-366-0221
Email	kazukiokamoto815@yahoo.co.jp

Public contact
Name of contact person	Kimiko Yuge
Organization	Kinki University School of Medicine
Division name	Department of gastroenterology and Hepatology
Address	377-2onohigashi osakasayama-shi osaka-hu
TEL	072-366-0221
Homepage URL
Email	kin-live@med.kindai.ac.jp

Sponsor
Institute	Kinki University School of Medicine,Department of gastroenterology and Hepatology
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	2016 Year 01 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 23 Day
Anticipated trial start date	2016 Year 03 Month 15 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	2016 Year 01 Month 23 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=R000023642