UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011074 |
|---|---|
| Receipt number | R000012963 |
| Scientific Title | The mid-term clinical study about the effect of curcumin for knee osteoarthritis |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2016/01/03 17:52:24 |
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Basic information
Public title
The mid-term clinical study about the effect of curcumin for knee osteoarthritis
Acronym
The mid-term study about the curcumin for knee osteoarthritis
Scientific Title
The mid-term clinical study about the effect of curcumin for knee osteoarthritis
Scientific Title:Acronym
The mid-term study about the curcumin for knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
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 6 months
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patient has curcumin
Interventions/Control_2
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 osteoarthritis and the Kelgren-Laurence classification stage II or III or IV
Key exclusion criteria
Operative case 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
Goshohigashi clinic
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）、御所東クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | 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
| 2013 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | 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
| 2013 | Year | 06 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012963
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
