UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053174 |
|---|---|
| Receipt number | R000060681 |
| Scientific Title | Effects of drinking carbonated water after bathing in a hot spring on the mind and body |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/20 12:29:14 |
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Basic information
Public title
Effects of drinking carbonated water after bathing in a hot spring on the mind and body
~Additional survey to observe the effects on the mind and body at hot spring bathing facilities in Beppu City (citizens' large scale measurement session)~
Acronym
Effects of drinking carbonated water after bathing in a hot spring on the mind and body
Scientific Title
Effects of drinking carbonated water after bathing in a hot spring on the mind and body
Scientific Title:Acronym
Effects of drinking carbonated water after bathing in a hot spring on the mind and body
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targeted people who participated in a survey to observe the effects on the mind and body of hot spring bathing facilities in Beppu City (citizens' large-scale measurement committee) and who were willing to cooperate in drinking carbonated water after bathing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective health status
Key secondary outcomes
Accelerated photoplethysmography, Heart rate valiability, Salivary amylase, Blood pressure, Flexibility
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
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Drinking carbonated water after bathing in a hot spring
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adults (18-90s) who consented to participate in the study.
Key exclusion criteria
Those who are prohibited from bathing by a doctor are excluded.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Hori |
Organization
B-biz LINK
Division name
President
Zip code
874-0938
Address
1-3, Suehirocho, Beppu city, Oita
TEL
0977-77-4513
hori.hikaru@b-bizlink.or.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hashimoto |
Organization
Asahi Soft Drinks Co., Ltd.
Division name
Research & Development Headquarters
Zip code
130-8602
Address
1-23-1 Azumabashi, Sumida-Ku, Tokyo
TEL
080-8196-1575
Homepage URL
hideki.hashimoto@asahiinryo.co.jp
Sponsor or person
Institute
B-biz LINK
Institute
Department
Personal name
Funding Source
Organization
Asahi Soft Drinks 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
Japan Health & Research institute
Address
3-1-4 Nihonbshi Chuo Tokyo Japan
Tel
03-5290-1621
info@jph-ri.or.jp
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
| 2023 | Year | 12 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060681
| 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 |
