UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The long term clinical study about the effect of curcumin for knee osteoarthritis
Title of the study (Brief title)	The long term study about the curcumin for knee osteoarthritis
Region	Japan

Condition
Condition	Osteoarthritis or osteochondral diseases in knee joints
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the clinical effect of the curcumin for knee osteoarthritis for 1 year
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JCOM, VAS, JAPANESE ORTHOPAEDIC ASSOCIATION KNEE OSTEOARTHRITIS SCORE, the volume of curcumin and NSAIDS, side effect, MRI T2 mapping, ultrasonic mechanical property of cartilage and blood concentration of curcumin
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patient has curcumin
Interventions/Control_2	Patient has placebo
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient has autogenous osteochondral grafts in his knee joint. Knee osteoarthritis, cartilage injury, osteochondratis dissecans and osteonecrosis etc.
Key exclusion criteria	Patient has poor general condition, intake of curcumin for long time or his knee operation during follow-up periods
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuaki Nakagawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Orthopaedic Surgery
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL	075-641-9161
Email	yanakaga@kyotolan.hosp.go.jp

Public contact
Name of contact person	yasuaki nakagawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Orthopaedic Surgery
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL	075-641-9161
Homepage URL
Email	yanakaga@kyotolan.hosp.go.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	THERAVALUES
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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	国立病院機構京都医療センター整形外科（京都府）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 16 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 24 Day
Anticipated trial start date	2013 Year 07 Month 16 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 29 Day
Last modified on	2019 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012964