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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023759
Receipt No. R000027378
Scientific Title Effectiveness of continuous warming by wrist mounted heat pad on Raynaud's symptoms in patients with connective tissue diseases
Date of disclosure of the study information 2016/08/25
Last modified on 2017/02/25

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Basic information
Public title Effectiveness of continuous warming by wrist mounted heat pad on Raynaud's symptoms in patients with connective tissue diseases
Acronym Wrist mounted heat pad on Raynaud's symptoms in connective tissue diseases
Scientific Title Effectiveness of continuous warming by wrist mounted heat pad on Raynaud's symptoms in patients with connective tissue diseases
Scientific Title:Acronym Wrist mounted heat pad on Raynaud's symptoms in connective tissue diseases
Region
Japan

Condition
Condition Raynaud's symptoms
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of continuous warming by wrist mounted heat pad on Raynaud's symptoms in Japanese patients with connective tissue diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in severity of Raynaud's symptoms, including the frequency and duration, by Raynaud's condition score and visual analog scale at two week after the treatment compared with the baseline
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The group of continuous warming by wrist mounted heat pad
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 Connective tissue disease patients with Raynaud's symptoms
Key exclusion criteria Patients with traumatic injury or skin manifestations on wrist joint; current smokers; patients who were started administration of drugs that affect peripheral circulation within three months; patients with diseases and past treatments that affect peripheral circulation except Raynaud's phenomenon; patients who cannot remove the heat pad of own will.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Azuma
Organization Hyogo College of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501 Japan
TEL 0798-45-6591
Email naoazuuh@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Azuma
Organization Hyogo College of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501 Japan
TEL 0798-45-6591
Homepage URL
Email naoazuuh@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
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 兵庫医科大学病院(兵庫県)(Hyogo College of Medicine Hospital (Hyogo))

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 25 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 Terminated
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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
2016 Year 08 Month 25 Day
Last modified on
2017 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027378

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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