UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of polyphenol-enriched oolong tea for the bowel preparation time; a single-blind randomized controlled clinical trial
Title of the study (Brief title)	Efficacy of polyphenol-enriched oolong tea for the bowel preparation time; a single-blind randomized controlled clinical trial
Region	Japan

Condition
Condition	Patients aged from 20 to 75 years who were undergoing colonoscopy at The Jikei University Hospital.
Classification by specialty	Medicine in general Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Polyphenol-enriched oolong tea has an effect of increasing lipid excretion. The aim of this study is to assess possibility of polyphenol-enriched oolong tea to reduce the time of colonoscopy bowel preparation and the total amount of reseiving Moviprep, water and oolong tea.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The elapsed time for bowel cleaning on the day of colonoscopy.
Key secondary outcomes	1.Patient acceptability score(PAS) 2.Procedure time(intubation time and observation time) 3.The total amount of reseiving Moviprep, water and polyphenol enriched oolong tea in the study 4.Aronchick Scale(to evaluate the bowel preparation) 5.The time of having the first bowel movement from the beginning of bowel preparation 6.The polyp detection rate of colonoscopy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Participants receiving PEG + Asc(Moviprep) took one sachet dissolved in 1 L of water followed by at least 0.5 L of polyphenol-enriched oolong tea at each administration.
Interventions/Control_2	Participants receiving PEG + Asc(Moviprep) took one sachet dissolved in 1 L of water followed by at least 0.5 L of water at each administration.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged from 20 to 75 years who were undergoing colonoscopy at the Jikei University Hospital, provided written informed consent were eligible for this study.
Key exclusion criteria	Patients were considered ineligible if any of the following were present: history of colorectal surgery, bowel obstruction because of intestinal stenosis, inflammatory bowel disease , chronic renal insufficiency(dialysis period), took Oolong Tea in the morning of the study day, was judged improper for the study.
Target sample size	280

Research contact person
Name of lead principal investigator	Kazuki Sumiyama
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Address	3-25-8 Nishi Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	ms05-takeishi@jikei.ac.jp

Public contact
Name of contact person	Hideka Horiuchi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Address	3-25-8 Nishi Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	ms05-takeishi@jikei.ac.jp

Sponsor
Institute	The Jikei University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	東京慈恵会医科大学附属病院(The Jikei University Hospital)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry	2017 Year 06 Month 07 Day
Date trial data considered complete	2017 Year 06 Month 07 Day
Date analysis concluded	2017 Year 06 Month 07 Day

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

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2017 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025214