The effect of saffron supplement on Antioxidative Status and Activity illness in patients with Ulcerative colitis

The effect of saffron supplementation on Antioxidative Status and activity illness in patients with Ulcerative colitis

The current study is designed as a randomized clinical trial. In this research, 96 eligible patients referring to Colorectal Research Center of Rasoul-e-Akram Hospital, Tehran were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.

In this study, patients with Ulcerative colitis referring to Hazrat Rasoul-e-Akram Hospital, who according to inclusion criteria and exclusion criteria, have the criteria to participate the study, would be asked to complete a written informed consent form. Individuals will be randomly assigned to receive intervention or placebo. Then, at the beginning and at the end of the study, 10 cc of fasting blood will be drawn. The level of TAC, SOD, GSH, MDA will be measured. At the beginning and the end of the study, anthropometric measurments and personal information questionnaires,activity illness, physical activity, and 24-hour recall are filled through interview.

The inclusion criteria of study are:Having the consent and Willingness to participate in study, age 18 and above. Also, the non-criteria of study include: changing the type and dosage of the drug over the past month, the incidence of other autoimmune diseases, pregnancy or lactation in women,the use of glucocorticosteroids over the past month and non-compliance with treatment (less than %80).

In current study, from 96 patients with Ulcerative colitis, 48 patients in the intervention group will receive 1 daily tablet containing 100 mg of saffron and 48 patients in the control group will use 1 daily placebo tablet containing Maltodextrin for 8 weeks.

activity illness; TAC; SOD; GSH; MDA

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.

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.

Only a section of the data, such as primary outcomes information or the like, will be shared.

Access period start 6 months after results publishing.

The obtained data from current study will be available only for working researchers in academic and scientific institutions.

Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis.

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

Applicants will be given access to the obtained data from current study by sending an email to the correspond author.