UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016632 |
|---|---|
| Receipt number | R000006659 |
| Scientific Title | Changes of renal blood flow by moxibustion in CKD patiants |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2015/02/25 15:13:38 |
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Basic information
Public title
Changes of renal blood flow by moxibustion in CKD patiants
Acronym
Changes of renal blood flow by moxibustion
Scientific Title
Changes of renal blood flow by moxibustion in CKD patiants
Scientific Title:Acronym
Changes of renal blood flow by moxibustion
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether moxibustion can change the renal blood flow or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of renal blood flow by moxibustion
(Resistive index)
Key secondary outcomes
PSV, EDV
HR
Blood pressure
Body temperature
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Indirect-moxibustion at BL23
Interventions/Control_2
Moxibustion is lighted at near to the patient's body to induce smoke and aroma for assesor blinding
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
Outpatients in department of nephrology of Gifu University Hospital.
Patients with CKD(grade1-5)
Key exclusion criteria
The patients who are administrated 40mg/day of steroid or more over.
Patients with a history of the past of the dermatopathia.
Patients with dermal fragility.
Patients who cannot sense heat stimulation.
Patients with stenosis of kidney artery.
Ineligibility for the study based on the decision of an investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichijiro Murata |
Organization
Gifu University
Division name
Department of nephrology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6523
kidney@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichijiro Murata |
Organization
Gifu University
Division name
Department of nephrology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6523
Homepage URL
kidney@gifu-u.ac.jp
Sponsor or person
Institute
Department of nephrology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
岐阜大学病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 25 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 25 | Day |
Last modified on
| 2015 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006659
