UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040070 |
|---|---|
| Receipt number | 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 13:34:10 |
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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
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
ishida-te@osaka-ganjun.jp
Sponsor or person
Institute
Osaka Center for Cancer and Cardiovascular Disease Prevention
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
