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IRCT20230511058153N1 IRCT 2023-06-13 Shahre-kord University of Medical Sciences The combined effect of mesalazine-crocin in the treatment of inflammatory bowel disease Comparison of the combined effect of mesalazine-crocin with mesalazine alone in the treatment of inflammatory bowel disease 2023-06-15 anticipated 40 Complete https://irct.ir/trial/70164 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the participants will be assigned to two groups A and B using the Random Allocation Rule method, and the number of ulcerative colitis and Crohn's patients will be equalized in the grouping. Group A (intervention group) will receive crocin capsules 15 mg twice a day in addition to the standard treatment (mesalazine 1000 mg tablets 3 times a day) and group B (control group) will receive the standard treatment plus placebo (in the form of crocin capsules) the same pharmaceutical company) will receive for 8 weeks, Randomization description: Participants will be assigned to two groups A and B using the Random Allocation Rule. 20 A cards for the intervention group and 20 B cards for the control group are placed in the lottery container. Cards are drawn randomly without replacement to create the desired sequence. And this process remains hidden from the researchers until the interventions are determined, Blinding description: The study will be Single blind. In such a way that only the patient is undemanding to which group he has been assigned, and the placebo capsule will be completely similar to the crocin capsule in terms of its shape and appearance. 3 Condition 1: Crohn's disease. Condition 2: Ulcerative colitis. Intervention 1: Intervention group: Standard treatment (Mesalazine tablet 1000 mg 3 times a day, Kimidaro Pharmaceutical Company) plus crocin capsule 15 mg (Darumed Pharmaceutical Company) twice a day for 8 weeks. Intervention 2: Control group: Standard treatment (mesalazine tablets 1000 mg 3 times a day, Kimidaro pharmaceutical company) plus placebo (in the form of crocin capsules and manufactured by the same Darumed pharmaceutical company) for 8 weeks. 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 Its release schedule is not yet known
public Ghorbanali Rahimian
Nurse Street, Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 rahimian29638@yahoo.com Shahre-kord University of Medical Sciences scientific Ghorbanali Rahimian
Nurse Street, Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 rahimian29638@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Inflammatory bowel diseases including Crohn's or ulcerative colitis Informed consent to participate in the study No history of other autoimmune diseases No history of underlying diseases No use of other medicinal plants Patients with moderate type Inflammatory bowel diseases Insensitivity to salicylates Insensitivity to any of the saffron compounds no limit no limit Both Reluctance to continue participating in the study Death of the patient Pregnancy or breastfeeding In case of any unwanted side effects K50 K51 Crohn's disease [regional enteritis] Ulcerative colitis Treatment - Drugs Placebo Intervention group: Standard treatment (Mesalazine tablet 1000 mg 3 times a day, Kimidaro Pharmaceutical Company) plus crocin capsule 15 mg (Darumed Pharmaceutical Company) twice a day for 8 weeks Control group: Standard treatment (mesalazine tablets 1000 mg 3 times a day, Kimidaro pharmaceutical company) plus placebo (in the form of crocin capsules and manufactured by the same Darumed pharmaceutical company) for 8 weeks The score of clinical symptoms of colitis in the Partial Mayo score questionnaire. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Partial Mayo score questionnaire. The score of the clinical symptoms of Crohn in the Harvey Bradshaw index questionnaire. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Harvey Bradshaw index questionnaire. Shahre-kord University of Medical Sciences Approved 2022-10-12 Ethics committee of shahrekord University of Medical Sciences Nurse St. - Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)