UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Fango on Osteoarthritis
Title of the study (Brief title)	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	Kenji Watanabe
Organization	Keio University
Division name	Faculty of Environment and Information studies
Address	5322 Endo, Fujisawa, Kanagawa
TEL	0466-49-6200
Email	watanabekenji@keio.jp

Public contact
Name of contact person	RYOJI HIROTA
Organization	Kochi University
Division name	Dept. of Environmental Medicine
Address	Kohasu, Oko, Nankoku, Kochi, Japan
TEL	0888802407
Homepage URL
Email	hirotar@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035713