UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000850 |
|---|---|
| Receipt number | R000001020 |
| Scientific Title | Development of method to evaluate anti-oxidative capability of Kampo in chronic kidney disease |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2008/12/12 08:13:13 |
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Basic information
Public title
Development of method to evaluate anti-oxidative capability of Kampo in chronic kidney disease
Acronym
Anti-oxidative action of Kampo in chronic kidney disease
Scientific Title
Development of method to evaluate anti-oxidative capability of Kampo in chronic kidney disease
Scientific Title:Acronym
Anti-oxidative action of Kampo in chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the anti-oxidative capacity of Kampo in chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
to evaluate the ability of Kampo to reduce oxidative stress with the use of oxidative/redox tiol compounds or monoclonal antibodies.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment group: administration of Hochu-ekki-tou (2.5g x 3/day) for 2 or 4 weeks
Interventions/Control_2
Control group: follow-up for 2-4 weeks without administration of Kampo
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
chronic kidney disease with serum creatinine level >=2.0mg/dl
Key exclusion criteria
patients taking other Kampo medication than Hochu-ekki-tou.
patients who have experienced adverse effects of Kampo medication.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KOICHI HAYASHI |
Organization
Department of Internal Medicine, School of Medicine, Keio University
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3796
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KOICHI HAYASHI |
Organization
Department of Internal Medicine, School of Medicine, Keio University
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3796
Homepage URL
khayashi@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 11 | Month | 01 | 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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 15 | Day |
Last modified on
| 2008 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001020
