The effect of saffron supplement on patients with Ulcerative colitis

Phase 3

Recruiting

• Conditions: lcerative colitis.; Ulcerative colitis

• Registration Number: IRCT20090822002365N21
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

The willingness to voluntarily participate in the study
The diagnosis of ulcerative colitis in the mild to moderate phase by the physician
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

Exclusion Criteria

Changing the type and dosage of the drug over the past month
The incidence of other autoimmune diseases, cancer
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
Pregnancy or lactation in women
Non-compliance with treatment (less than 80%)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Antioxidant Capacity (TAC). Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of TAC in serum using ELISA kit.;Superoxide dismutase (SOD). Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of SOD in serum using ELISA kit.;Malondialdehyde (MDA). Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of MDA in serum using ELISA kit.;Glutathione (GSH). Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of GSH in serum using ELISA kit.;Activity illness. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the SCCAI-Q questionnaire.

Secondary Outcome Measures

Name	Time	Method
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).;Weight. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Using the digital scale.