UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026194 |
|---|---|
| Receipt number | R000030088 |
| Scientific Title | Monitor test of the household hotpack |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2018/08/28 13:54:42 |
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Basic information
Public title
Monitor test of the household hotpack
Acronym
Monitor test of the household hotpack
Scientific Title
Monitor test of the household hotpack
Scientific Title:Acronym
Monitor test of the household hotpack
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectivness of household hotpac
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey on degree of physical condition improvement.
Key secondary outcomes
Questionnaire survey on temperature.
Questionnaire survey on size.
Questionnaire survey on ease of use.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
When subjects have pain, put a sample over clothes within 6 hours.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Japanese
(2) Female
(3) Age:20-45
(4) Having a pain periodically
(5) Health parson
Key exclusion criteria
(1) Subjects who have skin allergy and cutaneous hypersensitivity.
(2) Subjects who are diabetes, disease of hematogenous disorder, hyperhidrosis, other disease of abdomen.
(3) Subjects who have a piercing , tattoo,or trauma(scarred with bleeding) on use part.
(4) Subjects who are pregnant, could be pregnant in near future,or is breast feeding.
(5) Subjects who participate in other clinical study.
(6) Subjects who cause skin allergy symptoms(rash, redness, itching etc) by medicine, cosmetics, fomentations, plasters.
(7) Subjects who have a very good or bud warming.
(8)Subjects who have chronic pain on the west or in the abdomen.
(9) Subjects who are bacterial disease ,for example cystitis,food poisoning.
(10) Subjects who are judged as unsuitable for the study by the lead principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masyuki Yugi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Fundamental Research Department
Zip code
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0151
Yugi_masayuki@lotte.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhide Tokunaga |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Fundamental Research Department
Zip code
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0151
Homepage URL
tokunaga_yasuhide@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 21 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030088
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
