UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021788 |
|---|---|
| Receipt number | R000025127 |
| Scientific Title | The effects of the spa water ingestion on health-related factors |
| Date of disclosure of the study information | 2016/04/05 |
| Last modified on | 2018/04/10 09:59:24 |
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Basic information
Public title
The effects of the spa water ingestion on health-related factors
Acronym
Effects of spa water on health-related factors.
Scientific Title
The effects of the spa water ingestion on health-related factors
Scientific Title:Acronym
Effects of spa water on health-related factors.
Region
| Japan |
Condition
Condition
Non-specific
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was aimed to investigate the effects of the spa water about health-related factors in the community-dwelling residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related VAS and GSRS
Key secondary outcomes
Physical factors such as weight and blood pressure, as well as the state of defecation and urination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants drink the spa water (500 mL/day) every day during 4 weeks.
Interventions/Control_2
Controls do not drink the spa water during 4 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants, without a habit of drinking spa water and without the restriction of fluids, who can answer a self-reported questionnaire.
Key exclusion criteria
Participants who were unsuitable for study as judged by a doctor.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko KOTANI |
Organization
Jichi Medical University
Division name
Division of Community and Family Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, JAPAN
TEL
+81285587394
kazukotani@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko KOTANI |
Organization
Jichi Medical University
Division name
Division of Community and Family Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, JAPAN
TEL
+81285587394
Homepage URL
kazukotani@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Uenomura Clinic
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
| 2016 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kmj/67/3/67_207/_pdf/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kmj/67/3/67_207/_pdf/-char/en
Number of participants that the trial has enrolled
Results
There found to be significant
improvements in hair loss and the smell of feces in drinking group.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
-
Management information
Registered date
| 2016 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025127
| 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 |
