UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060186 |
|---|---|
| Receipt number | R000068842 |
| Scientific Title | Verification of the effectiveness of radon bath therapy for rheumatoid arthritis |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2025/12/23 23:25:39 |
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Basic information
Public title
Verification of the effectiveness of radon bath therapy for rheumatoid arthritis
Acronym
Radon Bath RCT for RA
Scientific Title
Verification of the effectiveness of radon bath therapy for rheumatoid arthritis
Scientific Title:Acronym
Radon Bath RCT for RA
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of effectiveness of radon bath therapy for rheumatoid arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate of the CDAI score at 1 month
Key secondary outcomes
Changes in Pain VAS and Patient Global Assessment at 0.5, 1, 3, 6, and 12 months following treatment initiation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bathing using radon-emitting ceramics, performed for 20 minutes per session, at least 5 days per week for 2 weeks.
Interventions/Control_2
Bathing using non-radon-emitting ceramics, performed for 20 minutes per session, at least 5 days per week for 2 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis (RA) who meet the 2010 ACR/EULAR classification criteria or the 1987 ACR classification criteria for RA, with low to moderate disease activity (CDAI 2.8-22.0), and who have been relatively stable with no changes in antirheumatic therapy for at least 3 months.
Key exclusion criteria
Patients scheduled for changes in antirheumatic therapy (addition or dose escalation)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Ohmura |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Rheumatology
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
ohmurako1964@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Ohmura |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Rheumatology
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
ohmurako1964@gmail.com
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe
Tel
078-302-4321
y_shimada@kcho.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
「福岡市民病院（福岡県）」「東海大学医学部付属病院（神奈川県）」
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068842
