UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025173 |
|---|---|
| Receipt number | R000028761 |
| Scientific Title | Effects of Okinawa mozuku on Defecation |
| Date of disclosure of the study information | 2016/12/08 |
| Last modified on | 2017/06/13 11:58:24 |
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Basic information
Public title
Effects of Okinawa mozuku on Defecation
Acronym
Effects of Okinawa mozuku on Defecation
Scientific Title
Effects of Okinawa mozuku on Defecation
Scientific Title:Acronym
Effects of Okinawa mozuku on Defecation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of bowel improvement effect of Okinawa Mosuku
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stool frequency, stool form, volume of stool
Key secondary outcomes
LDL-Cho, HDL-Cho, Total-Cho, body weight, BMI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Capsule containing Okinawa Mozuku(8cupsule/day, 8week)
Interventions/Control_2
Capsule not containing Okinawa Mozuku, plcebo(8cupsule/day, 8week)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age: 20-60, healthy men and women
(2) Stool frequency: 2-4/week
(3) Having defecation trouble
(4) BMI: <30
(5) Not having IBS
Key exclusion criteria
(1)Person who has a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, other severe disease.
(2)Those who have had surgery on the gastrointestinal tract
(3)those judged by the investigator as inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
tterashima@miula.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO 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
Address
Tel
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
| 2016 | Year | 12 | 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
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028761
