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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015770 |
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Date of registration:
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01/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease.
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Scientific title:
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Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. |
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Date of first enrolment:
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2014/09/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018353 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Goshi
Ishihara |
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Address:
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1F Kioicho Building, 3-12 Kioicho, Chiyoda-ku, Tokyo
102-0094
Japan |
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Telephone:
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03-3234-7677 |
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Email:
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curcumin-cd@theravalues.com |
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Affiliation:
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Theravalues Corporation Science group |
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Name:
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Hiroyuki
Hanai |
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Address:
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26 Shirowacho, Minami-ku, Hamamatsu, Shizuoka
Japan |
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Telephone:
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053-443-2111 |
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Email:
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flw-1013@topaz.plala.or.jp |
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Affiliation:
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Hamamatsu South Hospital Centre for Gastroenterology and Inflammatory Bowel Disease Research |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Crohn's disease (180 <= CDAI < 450) CDAI: Crohn's disease Activity Index
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Intervention(s)
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Standard therapy for Crohn's disease (Pentasa 3 g/day)
Patients take curcumin or placebo
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Primary Outcome(s)
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Crohn's disease Activity Index
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Secondary Outcome(s)
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> Decrease in dosage of steroid > Improvement of endoscopic score
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Source(s) of Monetary Support
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Theravalues Corporation
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Ethics review
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Status: YES
Approval date: 27/05/2014
Contact:
flw-1013@topaz.plala.or.jp
Hamamatsu South Hospital/Centre for Gastroenterology and Inflammatory Bowel Disease Research
053-443-2111
flw-1013@topaz.plala.or.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2017 |
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URL:
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