UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040070
Receipt No. R000045691
Scientific Title Single arm pilot study to evaluate the effectiveness of oolong tea in upper gastrointestinal endoscopy
Date of disclosure of the study information 2020/04/06
Last modified on 2020/04/15 (Ver. 3)

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Basic information
Public title Single arm pilot study to evaluate the effectiveness of oolong tea in upper gastrointestinal endoscopy
Acronym Single arm pilot study to evaluate the effectiveness of oolong tea in upper gastrointestinal endoscopy
Scientific Title Single arm pilot study to evaluate the effectiveness of oolong tea in upper gastrointestinal endoscopy
Scientific Title:Acronym Single arm pilot study to evaluate the effectiveness of oolong tea in upper gastrointestinal endoscopy
Region
Japan

Condition
Condition Person planning screening upper gastrointestinal endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of drinking oolong tea in improving visibility during upper gastrointestinal endoscopy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mucosal visibility score
Key secondary outcomes Examination time

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 Prevention
Type of intervention
Food
Interventions/Control_1 Drink 100ml of oolong tea 10-15 minutes before endoscopy
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
80 years-old >
Gender Male and Female
Key inclusion criteria Person planning screening upper gastrointestinal endoscopy
Key exclusion criteria 1)History of pharyngeal, esophageal, stomach, or duodenal surgery
2)History of allergy to oolong tea
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tetsushi
Middle name
Last name Ishida
Organization Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name Department of endoscopy
Zip code 536-8588
Address 1-6-107 Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL 06-6969-6711
Email ishida-te@osaka-ganjun.jp

Public contact
Name of contact person
1st name Tetsushi
Middle name
Last name Ishida
Organization Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name Department of endoscopy
Zip code 536-8588
Address 1-6-107 Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL 06-6969-6711
Homepage URL
Email ishida-te@osaka-ganjun.jp

Sponsor
Institute Osaka Center for Cancer and Cardiovascular Disease Prevention
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Osaka Center for Cancer and Cardiovascular Disease Prevention
Address 1-6-107 Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
Tel 06-6969-6711
Email kiyama@osaka-ganjun.jp

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
2020 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 5
Results 
Five people were enrolled in this study.
The mean age was 55.4 years (SD 6.0).
One was male and four were female.
The mean examination time was 456 seconds (SD 74.9).
The mean of total mucosal visibility score was 14.8 (SD 3.9).
Since simethicone/Pronase was additionally used in 2 cases, this study was discontinued in accordance with the protocol.
In 4 of 5 cases, the effectiveness of drinking oolong tea in improving visibility was hardly observed.
Results date posted
2020 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures 
none
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2020 Year 02 Month 21 Day
Date of IRB
2020 Year 03 Month 11 Day
Anticipated trial start date
2020 Year 04 Month 06 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 06 Day
Last modified on
2020 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045691