UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021788
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kazukotani@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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


Contact us.