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Effect of mesalasine in treatment of distal inflammation of intestine.

Phase 2
Conditions
lcerative Colitis.
Crohn disease of large intestine
Registration Number
IRCT201604307080N3
Lead Sponsor
Vice Chancellor for research of Babol University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Pateints older than 15 years old that have ulcerative colitis upon endoscopic and histologic criteria; severity of disease should be at least 3 of 12.

Exclusion criteria: Hypersensitivity to salicilate ; Active PUD; Important liver,renal or heart disease; Patients not respond to 5-ASA and on maintenance therapy with 5-ASA.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.;Endoscopic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Inde Questianaire.;Histopathologic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.
Secondary Outcome Measures
NameTimeMethod
Drug adverse reaction. Timepoint: 4 weaks after starting of study then every 3 month until one yesr. Method of measurement: Questionnaire.;Compliance to each treatment strategy. Timepoint: 4 weaks after starting of study then every 3 month until one yesr. Method of measurement: Questionare.
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