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IRCT20150927024228N5 IRCT 2023-12-18 Kerman University of Medical Sciences Investigation of the effect of Plantago major, and Rheum on colitis Efficacy of formula of Plantago major, and Rheum khorasanicum on clinical symptoms of patient with mild to moderate ulcerative colitis: a double blind randomized clinical trial 2024-03-10 anticipated 60 Complete https://irct.ir/trial/69653 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with mild to moderate ulcerative colitis based on Partial Mayo score, and inclusion, and exclusion criteria, will be entered into Excel file (Microsoft Excel® software 2021), then randomly sorted through using "RAND", and "INDEX" formulas. Then, simple randomized patients, in the order of the list of excel, will be entered into the two groups of the study (drug, or placebo) according to the list of 6 blocks of 4 below (ABAB, BABA, ABBA, BAAB, AABB, BBAA) by a trained secretory, who is blinded in details of the study, based on randomized excel file, Blinding description: Medicines and placebos are prepared by a traditional pharmacy specialist in the laboratory of the Iranian Faculty of Medicine, and after homogenization in terms of shape, smell, and color, they are provided to the researcher in completely similar packages. 3 Ulcerative colitis. Intervention 1: Intervention group: consumes 2 capsules daily contain two parts of Plantago major extract, and one part of Rheum khorasanicum prepared by the pharmacist in the pharmaceutical laboratory (1 in the morning and 1 in the evening) with a glass of water and before meals and with an interval of one hour from the mesalamine drug. Intervention 2: Control group: consumes 2 capsules contain corn starch prepared by the pharmacist in the pharmaceutical laboratory daily (1 in the morning and 1 in the evening) with a glass of water and before meals and with an interval of one hour from the mesalamine drug. 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 further information
public Maryam Azimi
Afzalipour hospital, Emam Khomeini highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3211 0123 Dr.azimm@gmail.com Kerman University of Medical Sciences scientific Azimi Maryam
Afzalipour hospital, Emam Khomeini highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 8000 dr.azimm@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 with mild and moderate ulcerative colitis confirmed by endoscopy and biopsy and diagnosed by a gastroenterologist who signed the informed consent form and did not meet the exclusion criteria. 18 years 60 years Both Pregnancy or breastfeeding Taking antibiotics Taking herbal medicines, NSAIDs, OCPs or hormone therapy (in the last 2 weeks) Complications of the disease (such as massive bleeding requiring hospitalization or emergency surgery, fulminant colitis, peritonitis, toxic megacolon, obstructive stenosis), Suffering from liver, kidney, heart, cancer or celiac disease at the same time Addiction to smoking or drugs Suffering from other autoimmune diseases K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: consumes 2 capsules daily contain two parts of Plantago major extract, and one part of Rheum khorasanicum prepared by the pharmacist in the pharmaceutical laboratory (1 in the morning and 1 in the evening) with a glass of water and before meals and with an interval of one hour from the mesalamine drug. Control group: consumes 2 capsules contain corn starch prepared by the pharmacist in the pharmaceutical laboratory daily (1 in the morning and 1 in the evening) with a glass of water and before meals and with an interval of one hour from the mesalamine drug. Partial Mayo score. Timepoint: At the beginning of the study, 3, 6 and 10 weeks. Method of measurement: Partial Mayo score questionnaire. Quality of life. Timepoint: At the beginning of the study, 3, 6 and 10 weeks. Method of measurement: Quality of life questionnaire (IBDQ-9). Anxiety, stress, and depression. Timepoint: At the beginning of the study, 3, 6 and 10 weeks. Method of measurement: DASS-21 questionnaire. Kerman University of Medical Sciences Approved 2023-02-14 Afzalipour Medical Education Center, Kerman University of Medical Sciences (Research Ethics Committ Afzalipour hospital, Emam Khomeini highway Kerman Kerman Iran (Islamic Republic of)