UMIN-CTR Clinical Trial

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
Email	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
Email	curcumin-cd@theravalues.com

Sponsor
Institute	Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018353