The effect of melatonin in Ulcerative colitis
Phase 3
Recruiting
- Conditions
- lcerative colitis.Ulcerative colitis
- Registration Number
- IRCT20121021011192N9
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
UC disease in patients with more than 20 years old
Exclusion Criteria
History of confirmed hypersensitivity reaction to melatonin or any parts of formulation
eGFR less than 30 ml/min/1.73m2
Liver failure (child pugh B, C)
Pregnancy & lactation
Uncontrolled seizure & untreated major depressive disorder
Concurrent use of fluvoxamine , nifedipine & non steroidal anti inflammatory drugs(NSAID)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Fecal calprotectin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Hange in high sensitivity CRP serum level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Change in Hemoglobin level. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Lab kits.;Improvement of clinical symptoms of uc. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on Simple clinical colitis activity index questionnaire.;Improvement of quality of life. Timepoint: Before intervention and 90 days after initiation of daily use of melatonin. Method of measurement: Interview with patients based on SF36 questionnaire.
- Secondary Outcome Measures
Name Time Method Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.