UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024402 |
|---|---|
| Receipt number | R000028058 |
| Scientific Title | Continued ingestion test of the plant extract containing food. |
| Date of disclosure of the study information | 2016/10/13 |
| Last modified on | 2016/10/24 10:46:14 |
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Basic information
Public title
Continued ingestion test of the plant extract containing food.
Acronym
Continued ingestion test of the plant extract containing food.
Scientific Title
Continued ingestion test of the plant extract containing food.
Scientific Title:Acronym
Continued ingestion test of the plant extract containing food.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the complaints of ingesting the plant extract containing food of healthy female.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Complaints.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)
Key secondary outcomes
Evaluation of Health Related Quality of Life.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of active once a day for 28days.
Interventions/Control_2
Ingestion of control1 once a day for 28days.
Interventions/Control_3
Ingestion of control2 once a day for 28days.
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1)Informed consent provided
2)Aged between50 and 69 women
3)Persons who have had stiffness in a month.
Key exclusion criteria
1)Persons who have possibilities for emerging allergy to foods.
2)Persons who have had rheumatism or disc herniation or collagen diseases or Parkinson's disease.
3)Persons who are considered inappropriate by the investigator or project leader.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Shioya |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-7251
shioya.yasushi@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiko Shudo |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-7464
Homepage URL
shudou.aiko@kao.co.jp
Sponsor or person
Institute
Macromill,Inc.
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
被験者自宅
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 14 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028058
