UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031277 |
|---|---|
| Receipt number | R000035713 |
| Scientific Title | Evaluation of Fango on Osteoarthritis |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2018/02/13 17:10:39 |
* 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
Evaluation of Fango on Osteoarthritis
Acronym
Evaluation of Fango on Osteoarthritis
Scientific Title
Evaluation of Fango on Osteoarthritis
Scientific Title:Acronym
Evaluation of Fango on Osteoarthritis
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cross over study of Mud therapy for relief pain in older people in Yugawara town.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thirty-Second Chair Stand test
Key secondary outcomes
Timed up and Go, Brief Pain Inventory Short Form, ADL
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mud therapy three times a week.
Interventions/Control_2
Topical application, NSAIDS
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee OA, Kellgen-Lawrence grade Class 1, class 2, class 3.
Key exclusion criteria
People with general contraindications of hyperthermia (acute inflammation, sensory disorders, circulatory disorder).
BMI > 30
Past or Current user of mud therapy
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Watanabe |
Organization
Keio University
Division name
Faculty of Environment and Information studies
Zip code
Address
5322 Endo, Fujisawa, Kanagawa
TEL
0466-49-6200
watanabekenji@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | RYOJI HIROTA |
Organization
Kochi University
Division name
Dept. of Environmental Medicine
Zip code
Address
Kohasu, Oko, Nankoku, Kochi, Japan
TEL
0888802407
Homepage URL
hirotar@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
RISTEX, Japan
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
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
| 2018 | Year | 02 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035713
