UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016517 |
|---|---|
| Receipt number | R000019179 |
| Scientific Title | The effect of coix seed on the skin color of chronic kidney disease patients |
| Date of disclosure of the study information | 2015/02/13 |
| Last modified on | 2019/08/17 10:34:32 |
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Basic information
Public title
The effect of coix seed on the skin color of chronic kidney disease patients
Acronym
The effect of coix seed on the skin color of chronic kidney disease patients
Scientific Title
The effect of coix seed on the skin color of chronic kidney disease patients
Scientific Title:Acronym
The effect of coix seed on the skin color of chronic kidney disease patients
Region
| Japan |
Condition
Condition
Chronic kidney disease patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effect of coix seed on the skin color of chronic kidney disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin color status of CKD patients were evaluated after a 1-month coix seed treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
CKD patients are divided into three groups (G3) according to GFR.
Each groups randomly assigned into treatment group(equitance 30ml, for 1 month) and placebo group.
Interventions/Control_2
CKD patients are divided into three groups (G4) according to GFR.
Each groups randomly assigned into treatment group(equitance 30ml, for 1 month) and placebo group.
Interventions/Control_3
CKD patients are divided into three groups (G5) according to GFR.
Each groups randomly assigned into treatment group(equitance 30ml, for 1 month) and placebo group.
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
| Not applicable |
Gender
Female
Key inclusion criteria
CKD patients, stage 3, 4, 5
Key exclusion criteria
1, Pregnant or breast-feeding woman
2, Worman received beauty salon treatments in the past 1 month.
3, Worman participating in a different clinical study.
4, Worman getting a suntan
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Horikoshi |
Organization
Juntendo University Hospital
Division name
Division of Nephrology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL
03-3813-3111
satoshi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Kihara |
Organization
Juntendo University Hospital
Division name
Division of Nephrology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
masao-k@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Juntendo University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2015 | 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
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019179
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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