This is a double blind controlled clinical trial in which patient aged between 18-70 years old with mild to moderate UC, in spite of maximum mesalamine treatment, divided in two groups of corchomin+mesalamine and placebo+mesalamine group, which is taken twice a day after breakfast and lunch. The diagnosis of UC was confirmed by endoscopy.
Sinacorchomine is a soft gelatinous capsule containing 40 and 80 milligram of nanomisceles of corchomine (minoo-tehran factory). Placebo is a soft gelatinous capsule without efficient corchomin products. At the beginning of the study all patients will be taught about appropriate diet and lifestyle. Patients will be visited every month for delivery of previous drug packages and handing over new capsules. Also taking pills will be followed every week with phone calls.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071435080N1
Registration date:2017-09-06, 1396/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Mehdi Moosavian
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1612
Email address
mmoosavian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences & Exir Nano Sina company
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluaation of Nano-micelle curcumin efficacy in patients whit mild to moderate ulcerative culities
Public title
Therapeutic effect of curcumin on ulcerative culities
Purpose
Treatment
Inclusion/Exclusion criteria
It’s a randomized double blind controlled trial in patients with mild to moderate ulcerative colitis which is under treatment with maximum dose of mesalamine. Patients aged between 18-70 years old with UC, which has been approved by endoscopy, will be enrolled. Mild to moderate active UC based on “simple clinical colitisactivity index (SCCAI) score” will be defined as <5 and <12 score, respectively. subjects with history of current or in past 12 weeks use of steroids, taking anti-TNF or cyclosporine, has Hgb<10 mg/dl or hematologic abnormalities including leukopenia, thrombocytopenia, those with impaired renal, coagulation or liver tests, subjects with positive C diff infection, pregnant patients, presence of active sepsis and nurses will be excluded from the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran university of medical science
Street address
city devision 6, poor sina street
City
Tehran
Postal code
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.2599
Health conditions studied
1
Description of health condition studied
ulcerative colitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Simple clinical colitisactivity index (SCCAI) score