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Therapeutic effect of curcumin on ulcerative culities

Phase 1
Conditions
ulcerative colitis.
Registration Number
IRCT2017071435080N1
Lead Sponsor
EXIR nano sina
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Simple clinical colitisactivity index (SCCAI) score. Timepoint: At the begining of study, 8 week after treatment. Method of measurement: questionairre.;Stool calprotectin. Timepoint: At the begining of study, 8 week after treatment. Method of measurement: lab test.;Mayo score. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: questionairre.;Serum cytokins(IFN-?, IL- 12, IL-4, IL-10, TGF-ß , IL-17). Timepoint: At the begining of study, 8 week after treatment. Method of measurement: lab test.;Grading scale for histological assessment of inflamation in ulcerative colitis. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: biopsy and lab test.;Self assessment scales for evaluating mood chracteristcs pre and post intervention. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: questionairre.;CRP. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: lab test.
Secondary Outcome Measures
NameTimeMethod
Hgb. Timepoint: At onset of study, end of study (8 week after treatment). Method of measurement: lab test.;Quantity of Bacteroidous family and colestridium. Timepoint: At onset of study, end of study (8 week after treatment). Method of measurement: lab test.
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