UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013344 |
|---|---|
| Receipt number | R000015573 |
| Scientific Title | Role of Epigallocatechin for the Prevention of Infections in Patients Treated with ImmunoSuppressive Therapy |
| Date of disclosure of the study information | 2014/03/07 |
| Last modified on | 2014/03/07 16:18:53 |
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Basic information
Public title
Role of Epigallocatechin for the Prevention of Infections in Patients Treated with ImmunoSuppressive Therapy
Acronym
Role of EpigalloCAtechin for the prevention of infections in patients treated with immunoSuppressive Therapy (RECAST)
Scientific Title
Role of Epigallocatechin for the Prevention of Infections in Patients Treated with ImmunoSuppressive Therapy
Scientific Title:Acronym
Role of EpigalloCAtechin for the prevention of infections in patients treated with immunoSuppressive Therapy (RECAST)
Region
| Japan |
Condition
Condition
Collagen Vascular Diseases
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of epigallocatechin on the prevention of infections in patients treated with immunosuppressive drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The events of bacterial and viral infections
Key secondary outcomes
The values of biomarkers suggesting viral and bacterial infections
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Roasted barley tea containing high epigallocatechin
Interventions/Control_2
Roasted barley tea without epigallocatechin
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients initiated with more than 30mg/day of prednisolone for the treatment of collagen vascular diseases
Key exclusion criteria
Patients already treated with more than 10mg/day of prednisolone
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Makino |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
in1246@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Takeuchi |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
t-takeuchi@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Research and development projects for application in promoting new policy of agriculture, forestry and fisheries
Organization
Division
Category of Funding 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
大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 02 | 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
| 2014 | Year | 03 | Month | 05 | Day |
Last modified on
| 2014 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
