UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021828 |
|---|---|
| Receipt number | 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 14:45:00 |
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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
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
e-kawasaki@tenjinkai.or.jp
Public contact
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
e-kawasaki@tenjinkai.or.jp
Sponsor or person
Institute
Shin-Koga Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025167
