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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015623
Receipt No. R000018156
Scientific Title Effects of the sparkling hot tab
Date of disclosure of the study information 2014/11/10
Last modified on 2014/11/07

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Basic information
Public title Effects of the sparkling hot tab
Acronym Hottab study
Scientific Title Effects of the sparkling hot tab
Scientific Title:Acronym Hottab study
Region
Japan

Condition
Condition Lifestyle disease
Classification by specialty
Medicine in general Cardiology Psychosomatic Internal Medicine
Dermatology Orthopedics Plastic surgery
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of sparkling hot tab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lymphocyte
Subjective status
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
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
Other
Interventions/Control_1 sparkling hot tab
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
59 years-old >=
Gender Female
Key inclusion criteria Healthy adults
Key exclusion criteria Who can not bathing
Target sample size 24

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuaki Goto
Organization Japan Health % Research Institute
Division name Onsen Medical Science Research Center
Zip code
Address 1-29-4, Nihonbashikakikara, Chuo
TEL 03-3668-1261
Email ygoto@jph-ri.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuaki Goto
Organization Japan Health % Research Institute
Division name Onsen Medical Science Research Center
Zip code
Address 1-29-4, Nihonbashikakikara, Chuo
TEL 03-3668-1261
Homepage URL
Email ygoto@jph-ri.or.jp

Sponsor
Institute Japan Health % Research Institute
Institute
Department

Funding Source
Organization HOT ALBUM Tansansen Tablet
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
2014 Year 11 Month 10 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 Enrolling by invitation
Date of protocol fixation
2014 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 30 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
2014 Year 11 Month 07 Day
Last modified on
2014 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018156

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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