Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients.

Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients receiving crocin compared with the group receiving placebo before and after the study.

A crossover clinical trial with placebo control group by parallel groups, double-blind, randomized, phase 3 on 60 patients. SPSS software was used for randomization.

Place of study: Porcine Hakim, Gastrointestinal and Liver Diseases Clinic, Isfahan; Study population: Adults with ulcerative colitis 18 to 65 years; Type of blinding: Double-blind including patients and researchers; Method of blinding: Through codes designed with SPSS by a third party

Inclusion criteria: Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis; positive Calprotectin; Adult patients from 18 years to 65 years; No use of other medicinal plants in the past 3 months; No allergy to saffron plant and its derivatives; Not taking new antidepressants and sleeping pills in the last 2 months; No use of new anti-inflammatory and antioxidant drugs in the last 3 months; Taking the usual medications prescribed by the doctor in the last 4 months. Exclusion criteria: Normal calprotectin ; Pregnancy or breastfeeding; In case of any side effects; Anticoagulant and warfarin use; A history of other underlying diseases and autoimmune diseases; alcohol consumption.

Intervention group: recipient of mesalamine with 15 mg of crocin twice daily Control group: receiving mesalamine with placebo containing starch twice a day

(calprotectin، NO،CRP، MPO،TNFα،IL-6،IL-1ß)؛(MDA،CAT، TAC, TOS,GSH)؛ (AMPK، SIRT-1، GLUT1، PKM2 )؛TG-CHOL-HDL-LDL؛CBCdiff؛Clinical symptoms;The fatty acid profile of RBC membranes;MCP-1;FBS;ALT,AST,ALP

Changes to the study design and the addition of a measurable outcome variable

30 patients with ulcerative colitis who are under standard treatment with mesalamine are selected. Randomization of samples is based on block randomization method. For random assignment with random numbers generated by SPSS software (use of random blocks with a volume of 6), each patient is assigned a code and then according to the treatment group assigned to the corresponding code, the patient is in one of the intervention groups to receive crocin or The control received a placebo.

In order to conduct this research in a double-blind manner, patients, researchers, clinical caregivers, outcome assessors, and data analysts are blinded by codes designed with SPSS by a third party (a person other than the researchers). Statistical software codes consist of Latin letters A and B along with numbers. The third party assigns one of the letters A and B included in the designed codes to the crocin group and the other to the placebo group. The codes are pasted on the cans containing crocin or placebo, and based on the code written on it, it is filled by the mentioned person and given to the researcher. Finally, without knowing the contents of the cans, the researcher randomly provides them to the patients.