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IRCT20240831062917N1 IRCT 2024-09-11 Esfahan University of Medical Sciences Investigating the effect of crocin in ulcerative colitis Investigating the effect of crocin on metabolic indices, inflammatory biomarkers and oxidative stress factors in ulcerative colitis patients. 2025-02-18 anticipated 30 Recruiting https://irct.ir/trial/78854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Ulcerative colitis. Intervention 1: Intervention group: Patients receiving the standard treatment of mesalamine plus two daily capsules of crocin (Samisaz company) for 12 weeks, orally, each containing 15 mg of crocin supplement. Intervention 2: Control group: Patients receiving standard treatment of mesalamine plus two placebo capsules containing starch daily for 12 weeks. The placebo will be completely similar to the crocin supplement in terms of shape and appearance of the package. Following a 21-day (3-week) wash-out period during which crocin and placebo are discontinued, the treatments are crossed over: the group previously receiving crocin is administered placebo, and the group previously receiving placebo is administered crocin. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mohammad hosein Aarabi
Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7052 mh.aarabi@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Hossein Aarabi
Department of Clinical Biochemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7052 mh.aarabi@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with ulcerative colitis proven through clinical diagnosis and previous colonoscopy results with mild-to-moderate colitis positive Calprotectin and receiving standard treatment of mesalamine 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. 18 years 65 years Both 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 Taking any anti-depressant, anti-inflammatory and new sleep medications in the last 2 months. Consumption of new anti-inflammatory and antioxidant drugs in the last 3 months. Change in commonly prescribed medications in the last 4 months. K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: Patients receiving the standard treatment of mesalamine plus two daily capsules of crocin (Samisaz company) for 12 weeks, orally, each containing 15 mg of crocin supplement. Control group: Patients receiving standard treatment of mesalamine plus two placebo capsules containing starch daily for 12 weeks. The placebo will be completely similar to the crocin supplement in terms of shape and appearance of the package. Following a 21-day (3-week) wash-out period during which crocin and placebo are discontinued, the treatments are crossed over: the group previously receiving crocin is administered placebo, and the group previously receiving placebo is administered crocin. Calprotectin. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA. Nitric oxide (NO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Myeloperoxidase (MPO). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Quantitative CRP. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Turbidimetry. Catalase. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Malondialdehyde (MDA). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity (TAC). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. AMPK gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR. SIRT-1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR. GLUT1 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR. PKM2 gen expression. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Real-time PCR. TNFα. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA. IL-6. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA. IL-1ß. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA. Ulcerative colitis disease activity index. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Truelove and Witts' classification. Cell Blood Count. diff. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Hematology cell counter. Quality of life in ulcerative colitis. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: 32-question IBD Quality of life questionnaire ( IBD Q-32 ). Triglycerides (TG). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry. Total cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry. HDL-Cholesterols. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: spectrophotometry. LDL-Cholesterol. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. The fatty acid profile of erythrocyte membranes. Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Gas Chromatography. Monocyte Chemoattractant Protein-1 (MCP-1). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: ELISA. Total Oxidant Capacity (TOS). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Glutathione(GSH). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Fasting Blood Sugar (FBS). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Alanine Aminotransferase (ALT). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Enzymatic kit. Aspartate Aminotransferase (AST). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Enzymatic kit. Alkaline phosphatase (ALP). Timepoint: Before the intervention and 12 weeks after the intervention. Method of measurement: Enzymatic kit. Esfahan University of Medical Sciences Approved 2024-07-31 Research Ethics committees of schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ Isfahan Isfehan Iran (Islamic Republic of) Approved 2025-06-07 Research Ethics committees of schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Building No. 4,Research and Technology Vice President ,Isfahan University of Medical Sciences, Hazar Jarib Ave, Azadi SQ Isfahan Isfehan Iran (Islamic Republic of)