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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028671
Receipt No. R000032825
Scientific Title Study of the effective material on the trouble by napkin
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/15

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Basic information
Public title Study of the effective material on the trouble by napkin
Acronym Study of the trouble by napkin
Scientific Title Study of the effective material on the trouble by napkin
Scientific Title:Acronym Study of the trouble by napkin
Region
Japan

Condition
Condition The trouble by the napkin in the women
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the troublr by the napkin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes the status of the skin
Key secondary outcomes PH

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 putting cosmetic material on the skin
Interventions/Control_2 putting no material on the skin
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
45 years-old >=
Gender Female
Key inclusion criteria the troublr by the napkin
Key exclusion criteria senstive skin
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Sengoku
Organization Asahikawa Medical University
Division name Department of OBGY
Zip code
Address Midorigaokahigashi2-1-1-1, Asahikawa, Hokkaido, Japan
TEL 0166-68-2562
Email ksen@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinobu Miyamoto
Organization Asahikawa Medical University
Division name Department of OBGY
Zip code
Address Midorigaokahigashi2-1-1-1, Asahikawa, Hokkaido, Japan
TEL 0166-68-2562
Homepage URL
Email toshim@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Self Funding
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
Email

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
2017 Year 09 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 08 Month 15 Day
Last modified on
2017 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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