Effect of Saffron supplementation on ulcerative colitis
Phase 3
- Conditions
- Ulcerative colitislcerative colitis.
- Registration Number
- IRCT20120415009472N18
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
The willingness to voluntarily participate in the study
The consumer of only one of the drug groups 5 -Amino salicylic acid (Pentasa, Mesalazine or Asacol), as well as azathioprine
BMI greater than 18.5 and less than 30
The diagnosis of ulcerative colitis in the mild to moderate phase by the physician
Exclusion Criteria
Changing the type and dosage of the drug over the past month
The incidence of other autoimmune diseases, cancer
Pregnancy or lactation in women
The use of multi vitamin-mineral supplements, antioxidants, and also the use of anticoagulants, blood cholesterol lowering drugs, anti-TNF drugs, and glucocorticosteroids over the past month
Non-compliance with treatment (less than %80)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IL-10. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;NF-kB. Timepoint: Before the intervention and two months later of intervention. Method of measurement: NF-kB activity in peripheral blood cells.;Quality of Life. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the IBDQ-9 questionnaire.;Hs-CRP. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-10 in serum using ELISA kit.;ESR. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Westergern method.
- Secondary Outcome Measures
Name Time Method Weight. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the digital scale.;Body Mass Index. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the ratio of weight (kilogram) to the square of height (meter).