UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015770 |
|---|---|
| Receipt number | R000018353 |
| Scientific Title | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2019/09/12 14:06:15 |
* 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
Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease.
Acronym
Exploratory study for effects of highly bioavailable curcumin on Crohn's disease.
Scientific Title
Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease.
Scientific Title:Acronym
Exploratory study for effects of highly bioavailable curcumin on Crohn's disease.
Region
| Japan |
Condition
Condition
Crohn's disease
(180 <= CDAI < 450)
CDAI: Crohn's disease Activity Index
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory for additive effects of highly bioavailable curcumin on standard treatment of active Crohn's disease (mild - moderate).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Crohn's disease Activity Index
Key secondary outcomes
> Decrease in dosage of steroid
> Improvement of endoscopic score
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Standard therapy for Crohn's disease (Pentasa 3 g/day)
Interventions/Control_2
Patients take curcumin or 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
> Disease located in small intestine, small/large intestine, or large intestine.
> 180 <= CDAI < 450
> For steroid administration, dosage is 10 mg/day or less as Predonine
Key exclusion criteria
> Using over 3 g/day mesalazine and/or topical formulation of mesalazine within 4 weeks.
> Using over 10 mg steroid as Predonine and/or a topical formulation of steroid, an immune modulator, or a biological drug within 4 weeks.
> Being steroid-dependent (relapse within 3 months without steroid).
> Pregnant or suspected of being pregnant.
> Having a history of a drug reaction(s) to Pentasa or Salicylic acid, etc.
> Having a dysfunction of the liver or kidney, and judged to be unsuitable for taking mesalazine.
> Confirming symptoms of stenosis such as stomachache or increased gurgle, or stenosis of 1/2 lumen by small bowel series.
> Being under the influence of a previous adverse reaction(s) from other clinical trials.
> Being under treatment for malignancy
> Short bowel syndrome by intestinal resection.
> Having had cytapheresis within 4 weeks.
> Judged to be unsuitable for enrollment for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hanai |
Organization
Hamamatsu South Hospital
Division name
Centre for Gastroenterology and Inflammatory Bowel Disease Research
Zip code
430-0846
Address
26 Shirowacho, Minami-ku, Hamamatsu, Shizuoka
TEL
053-443-2111
flw-1013@topaz.plala.or.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Ishihara |
Organization
Theravalues Corporation
Division name
Science group
Zip code
102-0094
Address
1F Kioicho Building, 3-12 Kioicho, Chiyoda-ku, Tokyo
TEL
03-3234-7677
Homepage URL
curcumin-cd@theravalues.com
Sponsor or person
Institute
Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research
Institute
Department
Personal name
Funding Source
Organization
Theravalues Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu South Hospital/Centre for Gastroenterology and Inflammatory Bowel Disease Research
Address
26 Shirowacho, Minami-ku, Hamamatsu, Shizuoka
Tel
053-443-2111
flw-1013@topaz.plala.or.jp
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
①浜松南病院消化器病（静岡県） Hamamatsu Minami Hospital
②浜松医科大学附属病院 (静岡県) Hamamatsu University Hospital
③札幌厚生病院（北海道） Sapporo-Kosei General Hospital
④久留米大学病院（福岡県） Kurume University Hospital
⑤東京慈恵会医科大学（東京都） Jikei University Hospital
⑥滋賀医科大学医学部附属病院（滋賀県） Shiga University of Medical Science Hospital
⑦京都大学医学部附属病院（京都府） Kyoto University Hospital
⑧島根大学医学部附属病院（島根県） Shimane University Hospital
⑨和歌山県立医科大学附属病院（和歌山県） Wakayama Medical University
⑩四日市羽津医療センター（三重県） Yokkaichi Hazu Medical Center
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
