UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about outcomes of Lymph-drainage for human legs.
Title of the study (Brief title)	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	NAKAO, Fujiko
Organization	Kumamoto University
Division name	Graduate school of Health Sciences
Address	4-24-1,Kuhonji, Kumamoto-city, Kumamoto
TEL	096-373-5495
Email	fu8nakao@kumamoto-u.ac.jp

Public contact
Name of contact person	NAKAO, Fujiko
Organization	Kumamoto University
Division name	Graduate school of Health Sciences
Address	4-24-1,Kuhonji, Kumamoto-city, Kumamoto
TEL	096-373-5495
Homepage URL
Email	fu8nakao@kumamoto-u.ac.jp

Sponsor
Institute	Graduate school of Health Sciences, Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028247