UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011075 |
|---|---|
| Receipt number | R000012964 |
| Scientific Title | The long term clinical study about the effect of curcumin for knee osteoarthritis |
| Date of disclosure of the study information | 2013/07/16 |
| Last modified on | 2019/01/05 11:14:43 |
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Basic information
Public title
The long term clinical study about the effect of curcumin for knee osteoarthritis
Acronym
The long term study about the curcumin for knee osteoarthritis
Scientific Title
The long term clinical study about the effect of curcumin for knee osteoarthritis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nakagawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
075-641-9161
yanakaga@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yasuaki nakagawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
075-641-9161
Homepage URL
yanakaga@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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)
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
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 |
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 24 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012964
