?Effectiveness of f Colon Specific Oral Formula containing Malva sylvesteris extract on Irritable Bowel Syndrome

Phase 3

Recruiting

• Conditions: lcerative colitis.; Ulcerative colitis

• Registration Number: IRCT20120305009204N4
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Medium or mild left sided colitis

Exclusion Criteria

Age under 18 and over 70 years
Addiction
Unwillingness to attend or continue to study
pregnacy
history of allergy to common mallow
Taking prednisolone above 15 mg daily and/or cyclosporine and/or infliximab within a month before intervention
Taking CNi; anti TNF; 6 MP or any antibiotics within a month before intervention
suffering from other inflammatory or non-infammatory bowel diseases such as neoplasms (observation of dysplasia in the tissue samples), polyposis, etc.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
C-reactive protein (C-RP) level. Timepoint: Before intervention and four weeks after intervention initiation. Method of measurement: Laboratory test.;Level of calpertectin in patients stool sample. Timepoint: Before intervention and four weeks after intervention initiation. Method of measurement: EISA Kit.

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Before and four weeks after intervention initiation. Method of measurement: Through the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQOL).;Complete blood count (CBC). Timepoint: Before and four weeks after intervention initiation. Method of measurement: Laboratory test.;Level of IL-6 in patients serum. Timepoint: Before and four weeks after intervention initiation. Method of measurement: ELISA Kit.