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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034907
Receipt No. R000039461
Scientific Title Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer
Date of disclosure of the study information 2018/11/16
Last modified on 2019/05/01

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Basic information
Public title Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer
Acronym UT-HEAL study
Scientific Title Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer
Scientific Title:Acronym UT-HEAL study
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is expected that cold sensation will relief by warming using a disposable warmer, but it has been unknown which part is suitable for warming. Therefore, we warm several sites on healthy volunteers and examine where comfortable and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scaling of "cold sensation" evaluate by each participants
Key secondary outcomes Visual analog scale data of interference degree on daily activities by wearing holder of warmers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Eighteen subjects wear a disposable warmer holder with disposable warmer and warm the neck, elbow, and wrist joints for one week in a predetermined order, respectively. Twelve subjects wear the holders only on the neck, elbow, and wrist joints for one week in the predetermined order,respectively.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy adults, equal or over 20yo and under 80.
2. A person who is conscious of cold end of extremities
3. The content of the explanatory document of this clinical research can be understood by the subject himself based on the explanation of the research director or research sharing person, and the written subject can be agreed in writing by the subject himself, Person who can observe and evaluate prescribed in the implementation plan and can report subjective symptoms etc.
Key exclusion criteria 1. A person who has some kind of skin disorder in the worn area of the body
2. A persons who have underlying diseases such as cardiovascular diseases, kidney diseases, liver diseases, blood diseases, autoimmune diseases and developmental disorders by interview, those whose pathology is not controlled by drug treatment or the like
3. A person who has diabetes
4. A persons with peripheral neuropathy or those who have previously undergone diagnosis of peripheral neuropathy (eg peripheral neuropathy due to cervical spondylosis, carpal tunnel syndrome, etc.)
5. A persons who have difficulty detaching the warmer holders with their own will
6. Other persons who have judged that the research director and research worker are inappropriate as subjects of this clinical study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshihito
Middle name
Last name Shima
Organization Osaka University Graduate School of Medicine
Division name Thermo-therapeutics for Vascular dysfunction
Zip code 565-0871
Address 1-3Yamada-oka, Suita, 5650871, Japan
TEL 06-6879-5710
Email ryanjin@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Akane
Middle name
Last name Watanabe
Organization Osaka University Graduate School of Medicine
Division name Thermo-therapeutics for Vascular dysfunction
Zip code 565-0871
Address 1-3Yamada-oka, Suita, 5650871, Japan
TEL 06-6879-5710
Homepage URL
Email a.watanabe@imed3.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Kiribai Chemical Co.,Ltd.
Kobayashi Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JP

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

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2Yamada-oka, Suita, 5650871, Japan
Tel 0662108296
Email handai-nintei@hp-crc.med.osaka-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 16 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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 16 Day
Date of IRB
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 04 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 16 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039461

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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