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IRCT20090822002365N21 IRCT 2018-04-09 Iran University of Medical Sciences The effect of saffron supplement on patients with Ulcerative colitis The effect of saffron supplement on Antioxidative Status and Activity illness in patients with Ulcerative colitis 2018-04-09 anticipated 96 Complete https://irct.ir/trial/29898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 96 subjects, 24 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will enter based on the sequence produced into study and the drug packets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as a random sequence produced during the study will be immune from prediction, Blinding description: In order to performing the double-blinded of study, before study beginning, the canisters containing saffron tablets can be provided by someone other than the researcher, and the placebo tablets in appearance are similar to the saffron tablets and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period. 3 Ulcerative colitis. Intervention 1: Intervention group: Daily intake of one saffron tablet (100 mg) for 8 weeks (2 months). Intervention 2: Control group: Daily intake of one placebo tablet (containing Maltodextrin) for 8 weeks (2 months). Yes - There is a plan to make this available What will be shared: Only a section of the data, such as primary outcomes information or the like, will be shared. When: Access period start 6 months after results publishing. To whom: The obtained data from current study will be available only for working researchers in academic and scientific institutions. Conditions: Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis. Where to obtain: Applicants can be communicated to correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran university of Medical Sciences, Hemat Express way, Tehran Cell phone:+98 21 8670 4743 Email:vafa.m@iums.ac How to obtain: Applicants will be given access to the obtained data from current study by sending an email to the correspond author. Comments:
public Mohammadreza Vafa
Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehranan University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 vafa.m@iums.ac.ir Iran University of Medical Sciences scientific Mohmmadreza Vafa
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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%) K51 Ulcerative colitis Treatment - Other Placebo Intervention group: Daily intake of one saffron tablet (100 mg) for 8 weeks (2 months). Control group: Daily intake of one placebo tablet (containing Maltodextrin) for 8 weeks (2 months) 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. 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. Iran University of Medical Sciences Approved 2018-02-12 Ethics committee of Iran University of Medical Science Iran University of Medical Science, Hemmat Express way Tehran Tehran Iran (Islamic Republic of)