UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015623 |
|---|---|
| Receipt number | 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 02:03:56 |
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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
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
ygoto@jph-ri.or.jp
Public contact
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
ygoto@jph-ri.or.jp
Sponsor or person
Institute
Japan Health % Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
