UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034099 |
|---|---|
| Receipt number | R000038865 |
| Scientific Title | Safty comfirmation examination of the plant fermentation extract IL |
| Date of disclosure of the study information | 2018/09/11 |
| Last modified on | 2018/09/11 18:33:02 |
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Basic information
Public title
Safty comfirmation examination of the plant fermentation extract IL
Acronym
Safty comfirmation examination of the plant fermentation extract IL
Scientific Title
Safty comfirmation examination of the plant fermentation extract IL
Scientific Title:Acronym
Safty comfirmation examination of the plant fermentation extract IL
Region
| Japan |
Condition
Condition
healthy people and mild constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirm safety about intakes for 25ml per day in "the plant fermentation extract IL" about 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We perform the blood test before and after "plant fermentation extract IL" intake and confirm safety.
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
The subjects eat the test meal each day per 25ml for 4 weeks. Then we carry out the blood tests at baseline and after 4weeks.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1)The person who does not take medicine for treatment
2) The tendency to slight constipation (in a week 2-4 times)
3) The person who does not take bowel movement improvement medicine for examination one month.
4) The person who, during the test, can do it constantly in life.
5) The one that was admitted by the judgment of the examination responsibility doctor
Key exclusion criteria
1) The one with a serious disease.
2) A disease anamnesis and the alimentary system with the operation calendar of the digestive organs.
3) The person who, during the test, cannot do it constantly in life.
4) Is the person with allergy for test food.
5) The person who is pregnant, and hopes for the pregnancy during an examination.
6) The doctor examination responsibility who was ineligible by a judgment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tanaka |
Organization
Kagawa Nutrition University
Division name
Nutrition Clnic
Zip code
Address
3-34-3,Komagome,Tosima-ku,Tokyo
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3,Komagome,Tosima-ku,Tokyo
TEL
03-3918-6181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
kagawa nutrition university
Institute
Department
Personal name
Funding Source
Organization
International food Co.Ltd.
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 09 | Month | 11 | 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
| 2018 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | 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
| 2018 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038865
