UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027474 |
|---|---|
| Receipt number | R000031474 |
| Scientific Title | Effect of medicinal diet on various abnormal condition in Oriental Medicine |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2017/05/24 12:44:34 |
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Basic information
Public title
Effect of medicinal diet on various abnormal condition in Oriental Medicine
Acronym
Effect of medicinal diet on various abnormal condition in Oriental Medicine
Scientific Title
Effect of medicinal diet on various abnormal condition in Oriental Medicine
Scientific Title:Acronym
Effect of medicinal diet on various abnormal condition in Oriental Medicine
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of improving abnormalities in Oriental medicine by continuous taking of medicinal diet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of Oriental medicine abnormal constitution by questionnaire form
Key secondary outcomes
Improvement of various stress markers
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
Taking medicinal diet for 1 week, then washing out for 1 week, then taking normal meal for 1 week
Taking it as a lunch
Interventions/Control_2
Taking normal meal for 1 week, then washing out for 1 week, then taking medicinal diet for 1 week
Taking it as a lunch
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No abnormality in Western medicine, but abnormal constitution as Oriental medicine
Key exclusion criteria
1)Suspected food allergies
2)Taking some treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ko Nishimura |
Organization
Suzuka University of Medical Science
Division name
Institute of Traditional Chinese Medicine
Zip code
Address
1275-3, Kishioka-cho, Suzuka, 510-0226, Mie
TEL
059-381-2385
ko-n@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Takagi |
Organization
Suzuka University of Medical Science
Division name
Institute of Traditional Chinese Medicine
Zip code
Address
1275-3, Kishioka-cho, Suzuka, 510-0226, Mie
TEL
059-381-2385
Homepage URL
takagi17@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
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
| 2017 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 05 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031474
