UMIN-CTR Clinical Trial

Public title

Efficacy of polyphenol-enriched oolong tea for the bowel preparation time;
a single-blind randomized controlled clinical trial

Acronym

Efficacy of polyphenol-enriched oolong tea for the bowel preparation time;
a single-blind randomized controlled clinical trial

Scientific Title

Efficacy of polyphenol-enriched oolong tea for the bowel preparation time;
a single-blind randomized controlled clinical trial

Scientific Title:Acronym

Efficacy of polyphenol-enriched oolong tea for the bowel preparation time;
a single-blind randomized controlled clinical trial

Region

Japan

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

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kazuki Sumiyama

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

3-25-8 Nishi Shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

ms05-takeishi@jikei.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideka Horiuchi

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

3-25-8 Nishi Shinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL

Email

ms05-takeishi@jikei.ac.jp

Institute

The Jikei University of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京慈恵会医科大学附属病院(The Jikei University Hospital)

Date of disclosure of the study information

2016

Year

05

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2016

Year

03

Month

14

Day

Date of IRB

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

Other related information

Registered date

2016

Year

05

Month

02

Day

Last modified on

2017

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025214