UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035675 |
|---|---|
| Receipt number | R000040583 |
| Scientific Title | Effects of two components of herbal medicine on kidney function |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2019/02/01 10:05:26 |
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Basic information
Public title
Effects of two components of herbal medicine on kidney function
Acronym
Effects of two components of herbal medicine on kidney function
Scientific Title
Effects of two components of herbal medicine on kidney function
Scientific Title:Acronym
Effects of two components of herbal medicine on kidney function
Region
| Japan |
Condition
Condition
Kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of the renal function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement effect of the renal
Key secondary outcomes
Improvement effect of carotid artery IMT
Improvement effect of CAVI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
astragali radix 1 day 6.0g, 1 year
Interventions/Control_2
angelicae radix 1 day 1.5g, 1 year
Interventions/Control_3
ginseng radix 1 day 1.5g, 1 year
Interventions/Control_4
rhubarb 1 day 0.5~1.5g, 1 year
Interventions/Control_5
glycyrrhiza 1 day 2.0g, 1 year
Interventions/Control_6
carotid artery IMT
Interventions/Control_7
CAVI
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eGFR<60
Key exclusion criteria
eGFR>=60
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Fushimi |
Organization
Fushimi clinic
Division name
Internal medicine
Zip code
Address
5-4-16 Minamiku, izumida, Okayama city, Okayama, Japan
TEL
086-241-3480
fusimi-i@po.harenet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Fushimi |
Organization
Fushimi clinic
Division name
Internal medicine
Zip code
Address
5-4-16 Minamiku, Izumida, Okayama city, Okayama, Japan
TEL
086-241-3480
Homepage URL
fusimi-i@po.harenet.ne.jp
Sponsor or person
Institute
Fushimi clinic
Institute
Department
Personal name
Funding Source
Organization
Fushimi clinic
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
| 2020 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | 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
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040583
