UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024657 |
|---|---|
| Receipt number | R000028247 |
| Scientific Title | Study about outcomes of Lymph-drainage for human legs. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/10/31 20:13:25 |
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Basic information
Public title
Study about outcomes of Lymph-drainage for human legs.
Acronym
Outcomes of Lymph-drainage
Scientific Title
Study about outcomes of Lymph-drainage for human legs.
Scientific Title:Acronym
Outcomes of Lymph-drainage
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the outcomes of Lymph-drainage.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The fegs with circumferences, composition of water,mascle and fat of each leg.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
One person per 2 times. First, a participant lay down, and the other day she has Lymph-drainage for 30 minutes.
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who do not operated on her abdomin.
Key exclusion criteria
Pregnant women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAO, Fujiko |
Organization
Kumamoto University
Division name
Graduate school of Health Sciences
Zip code
Address
4-24-1,Kuhonji, Kumamoto-city, Kumamoto
TEL
096-373-5495
fu8nakao@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAKAO, Fujiko |
Organization
Kumamoto University
Division name
Graduate school of Health Sciences
Zip code
Address
4-24-1,Kuhonji, Kumamoto-city, Kumamoto
TEL
096-373-5495
Homepage URL
fu8nakao@kumamoto-u.ac.jp
Sponsor or person
Institute
Graduate school of Health Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Governmental office
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
熊本大学医学部付属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | 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
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028247
