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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026194
Receipt No. 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

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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
Obsterics 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
Email 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
Email tokunaga_yasuhide@lotte.co.jp

Sponsor
Institute Lotte Co., Ltd.
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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