UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045115 |
|---|---|
| Receipt number | R000051538 |
| Scientific Title | Improvements on glycation by thermal effects of balneotherapy |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/10 18:07:27 |
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Basic information
Public title
Improvements on glycation by thermal effects of balneotherapy
Acronym
Improvements on glycation by thermal effects of balneotherapy
Scientific Title
Improvements on glycation by thermal effects of balneotherapy
Scientific Title:Acronym
Improvements on glycation by thermal effects of balneotherapy
Region
| Japan |
Condition
Condition
Patients with impaired glucose tolerance
Healthy subjects
Patients with chronic pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the glycation reaction and oxidative balance system by one-week balneotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the state of red blood cell deformation by dark field microscopy
Key secondary outcomes
Changes in AGEs levels
Changes in the oxidative stress (reactive oxygen metabolites, d-ROM), antioxidant power (biological antioxidant potential, BAP), and potential antioxidant capacity (BAP/d-ROM ratio)
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
| Behavior,custom |
Interventions/Control_1
The subjects stayed at the hotel with hot springs for one-week and took hot spring baths twice a day for 20 min (balneotherapy).
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age: 20-75 years
2)Male or Female
3)Provided written consent to participate in this study
Key exclusion criteria
1) Current smoker
2) Alcohol intake
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsutaro |
| Middle name | |
| Last name | Nagata |
Organization
International Foundation of Comprehensive Medicine
Division name
Chiyoda International Clinic
Zip code
101-0053
Address
11-8, SK Mitoshirocho-building 5F, Kanda-Mitoshirocho,Chiyoda-ku,Tokyo, 101-0053,Japan
TEL
03-5577-6841
shiwa-ifcm@nifty.com
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Shiwa |
Organization
International Foundation of Comprehensive Medicine
Division name
Chiyoda International Clinic
Zip code
101-0053
Address
11-8, SK Mitoshirocho-building 5F, Kanda-Mitoshirocho,Chiyoda-ku,Tokyo, 101-0053,Japan
TEL
03-5577-6841
Homepage URL
shiwa-ifcm@nifty.com
Sponsor or person
Institute
International Foundation of Comprehensive Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Balneotherapy Climatology and Physical Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International Foundation of Comprehensive Medicine
Address
11-8, SK Mitoshirocho-building 5F, Kanda-Mitoshirocho,Chiyoda-ku,Tokyo, 101-0053,Japan
Tel
03-5577-6841
ifcm@nifty.com
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
| 2021 | Year | 08 | 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
11
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051538
| 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 |
