UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036196 |
|---|---|
| Receipt number | R000040765 |
| Scientific Title | Verification study of Bowel Movement Improvement by Amazake Consumption |
| Date of disclosure of the study information | 2019/03/15 |
| Last modified on | 2020/08/03 17:03:00 |
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Basic information
Public title
Verification study of Bowel Movement Improvement by Amazake Consumption
Acronym
Verification study of Bowel Movement Improvement by Amazake Consumption
Scientific Title
Verification study of Bowel Movement Improvement by Amazake Consumption
Scientific Title:Acronym
Verification study of Bowel Movement Improvement by Amazake Consumption
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification study of Bowel Movement Improvement by Amazake Consumption
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of bowel movements per day,
amount of stools, strength of odor, state of the stool, sensation after defecation per bowel movement.
Key secondary outcomes
number of tablets of the magnesium carbonate which ingested per day
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
190g of Amazake using the lees and rice koji, 1 bottle per day
Interventions/Control_2
190g of hot water, 1 cup per day
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1) Person who regular visits at Matsuo Clinic
2) Women with mild constipation who are prescribed magnesium oxide at the age of 20 to 60 years at the time of obtaining informed consent for study participation
3) Person who have be given sufficient explanation about the purpose and contents of this study, has the ability to agree, volunteer for voluntary participation with good understanding, and can consent to this examination in writing
4) Person who can come to the Matsuike Clinic on the designated day and receive an interview
5) Person who were considered appropriate to participate in this study by the study doctor
Key exclusion criteria
1) Person who have symptoms other than mild constipation
2) Person who is no history of visits for the past 3 months
3) Person who have some factor that the examining physician can not judge the affect to the study
4) Person who may be allergic to the test food ingredients
5) Person who regularly drink sweet sake (manufacturer is not matter)
6) Person who plan pregnancy, lactation or pregnancy possibility and pregnancy during the study period
7) Person with alcoholism or other mental disorders
8) Person who may change lifestyle during the examination period (night work, long trips, etc.)
9) Person who are planning to take health functional food or supplement food during the test period
10) Person who received treatment with hospitalization within the past 6 months
11) Person who are currently participating in other clinical trials, or person who have not passed three months after participating in other clinical trials
12) Person who the study doctor judged as inappropriate for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Morita |
Organization
Morinaga & CO., LTD.
Division name
R & D institute
Zip code
230-8514
Address
2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan
TEL
045-571-2982
m-morita-je@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
Morinaga & CO., LTD.
Division name
R & D institute
Zip code
230-8514
Address
2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan
TEL
045-571-2982
Homepage URL
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
Morinaga & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & CO., LTD.
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
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401,Mita,Minato-ku,Tokyo,Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
松生クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 15 | 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
38
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
Main results already published
Date of protocol fixation
| 2018 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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 | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040765
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| Registered date | File name |
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