UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036320 |
|---|---|
| Receipt number | R000041377 |
| Scientific Title | A study of bowel movement improving effect by consumption of super barley "BARLEYmax" |
| Date of disclosure of the study information | 2019/04/08 |
| Last modified on | 2020/09/28 18:22:40 |
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Basic information
Public title
Bowel movement improving test by consumption of "BARLEYmax"
Acronym
Bowel movement improving test by consumption of "BARLEYmax"
Scientific Title
A study of bowel movement improving effect by consumption of super barley "BARLEYmax"
Scientific Title:Acronym
A study of bowel movement improving effect by consumption of super barley "BARLEYmax"
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the bowel movement improving effect by consumption of functional barley (super barley "BARLEYmax", by means of questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Comparison using-dose fluctuation of the laxative (Magnesium oxidative) between before consumption and after consumption by questionnaire.
*Comparison the number of defecation between before consumption and after consumption by questionnaire.
*Comparison the amount of defecation between before consumption and after consumption by questionnaire.
*Comparison the feces properties (hardness of feces) between before consumption and after consumption by questionnaire.
*Comparison the feelings after defecation between before consumption and after consumption by questionnaire.
*Comparison the health condition between before consumption and after consumption by questionnaire.
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake steamed barley containing 12g of functional barley (super barley "BARLEYmax") every day for one month. The timing of intake isn't specified.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 and older.
2) Subjects who have received medical examination due to constipation and use magnesium oxidative as laxative.
3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria
Subjects who have received medical examination due to constipation but who don't use Magnesium oxidative as laxative.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuneo |
| Middle name | |
| Last name | Matsuike |
Organization
Matsuike Clinic
Division name
Director
Zip code
190-0021
Address
2-12-27, Hagoromo-cho, Tachikawa-city, Tokyo 190-0021, JAPAN
TEL
042-522-7713
IRB@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Matsuura |
Organization
Integrate co.,ltd.
Division name
Integrated Solution Division
Zip code
151-0051
Address
Park Avenue, 1-20-1, Sendagaya, Shibuya-ku, Tokyo 151-0051, JAPAN
TEL
03-5771-9960
Homepage URL
k.matsuura@itgr.co.jp
Sponsor or person
Institute
Matsuike Clinic
Institute
Department
Personal name
Funding Source
Organization
TEIJIN LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2019 | Year | 04 | Month | 08 | 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
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041377
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
