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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021828
Receipt No. R000025167
Scientific Title Investigation of clinical test at foot conditions.
Date of disclosure of the study information 2016/04/08
Last modified on 2016/10/06

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Basic information
Public title Investigation of clinical test at foot conditions.
Acronym Clinical test of foot conditions.
Scientific Title Investigation of clinical test at foot conditions.
Scientific Title:Acronym Clinical test of foot conditions.
Region
Japan

Condition
Condition Patients with endocrine and metabolic diseases
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical test of foot conditions to patients with endocrine and metabolic diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjects continue two kinds of practices for each one month. During these two practices, subjects do not operate for one month. Subjects will be evaluate complaint changes, skin conditions, gravimetric test, senses, and blood analysis four times for every visit.
Key secondary outcomes QOL of subjects
Doctor's diagnosis for practice.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply one foot practice A for 10 minutes and for once a day and at least five times a week. Maintain the foot practice for one month ->washout 1 month -> Apply one foot practice B for 10 minutes and for once a day and at least five times a week. Maintain the foot practice for one month.
Interventions/Control_2 Apply one foot practice B for 10 minutes and for once a day and at least five times a week. Maintain the foot practice for one month ->washout 1 month -> Apply one foot practice A for 10 minutes and for once a day and at least five times a week. Maintain the foot practice for one month.
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
18 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria -Patient with endocrine and metabolic diseases
Key exclusion criteria -Subjects with atopic dermatitis, eczema and pollen allergy
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Eiji Kawaski, M.D., Ph.D.
Organization Shin-Koga Hospital
Division name Vice President
Zip code
Address 120 Tenjin-cho, Kurume 830-8577, Japan
TEL 0942-38-2222
Email e-kawasaki@tenjinkai.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Eiji Kawaski, M.D., Ph.D.
Organization Shin-Koga Hospital
Division name Vice President
Zip code
Address 120 Tenjin-cho, Kurume 830-8577, Japan
TEL 0942-38-2222
Homepage URL
Email e-kawasaki@tenjinkai.or.jp

Sponsor
Institute Shin-Koga Hospital
Institute
Department

Funding Source
Organization Kao Corporation
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
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 社会医療法人天神会 新古賀病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 08 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
2016 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 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 04 Month 07 Day
Last modified on
2016 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025167

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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