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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036895
Receipt No. R000042048
Scientific Title Availability of itching scales to put them on an automatic questionnaire system: an prospective observational study
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/20

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Basic information
Public title Availability of itching scales to put them on an automatic questionnaire system: an prospective observational study
Acronym Availability of itching scales to put them on an automatic questionnaire system: an prospective observational study
Scientific Title Availability of itching scales to put them on an automatic questionnaire system: an prospective observational study
Scientific Title:Acronym Availability of itching scales to put them on an automatic questionnaire system: an prospective observational study
Region
Japan

Condition
Condition Itchy skin
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To follow the change of itchy symptom using an medical questionnaire of dermatitis and the cutaneous pruritus and 2) to investigate the responsiveness (rate of change) of each questionnaire.
In addition, 3) to evaluate blood parameters which are possible factors to have an influence on the responsiveness of the medical questionnaire.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Responsiveness of medical questionnaire about itch.(POEM, EASI, 5D-J, Skindex 16)
Key secondary outcomes (1)Comparison among medical questionnaire about itch.
(2)Alteration of each observation items
(3) Relationship between each medical questionnaire about itch, and study subject background or alteration of observation items.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with itchy skin who consult the Kampo Clinic at Keio University Hospital by March, 2020
Key exclusion criteria 1) Patients who took Kampo medicine within four weeks before registration
2) Patients with the experience an allergy after taking any Kampo medicine
3) Patients who used oral or intravenous steroid preparation within four weeks before registration
4) Patients who were judged not to be included by researchers
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Mimura
Organization Keio University School of Medicine
Division name Center for Kampo Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5366-3824
Email mimura@keio.jp

Public contact
Name of contact person
1st name Tetsuhiro
Middle name
Last name Yoshino
Organization Keio University School of Medicine
Division name Center for Kampo Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5366-3824
Homepage URL
Email tetta213@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization TUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine IRB
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.jp

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 06 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 Open public recruiting
Date of protocol fixation
2019 Year 04 Month 08 Day
Date of IRB
2019 Year 05 Month 20 Day
Anticipated trial start date
2019 Year 06 Month 20 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 07 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information Follow up the symptom using an medical questionnaire of dermatitis and the cutaneous pruritus and investigate the responsiveness (rate of change) of each medical questionnaire. In addition, even if there is blood parameter in conjunction with a feeling of itch, and investigate a factor to have an influence on the responsiveness of the medical questionnaire.

Management information
Registered date
2019 Year 05 Month 30 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042048

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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