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IRCT20220115053713N2 IRCT 2022-04-16 Mashhad University of Medical Sciences Mebendazole in combination with mesalamine against Ulcerative colitis To investigate the therapeutic potency of Mebendazole in combination with standard treatment, mesalamine, in Ulcerative colitis patients 2022-04-21 anticipated 54 Complete https://irct.ir/trial/61314 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It is a Block randomized trial in which the Random Allocation Software will be used for allocation concealment which is performed according to SNOSE (sequentially numbered, opaque, sealed envelopes) technique. Envelopes will be sealed and one of the executive member will put randomized number into pockets . Following providing written documentation of informed consent to participate the subjects will pick up a pocket which will be divided into control or intervention group accordingly. Size of Blocks will be four in the study, Blinding description: This is a double-blind clinical trial in which participants and data analyzers will be blinded to the study. In this randomized controlled trial blinding is achieved with placebo. Compared to the treatment, plecebo will have the same shape and color. Since double-blinded studies are considered valid approach in decreasing bias in clinical trials, both participants and data analyzers are blinded in this study. It is worth mentioning that participants are aware that they might be randomly categorized either in the treatment or control group. The principal investigator is responsible for the safety of the project, assessing results, and writing the manuscript. He is not blinded to final outcomes. Data collectors, Data analyzers will be blinded in this study. Data Safety and Monitoring Board are not blind to data. 3 Condition 1: Ulcerative (chronic) rectosigmoiditis. Condition 2: Left sided colitis, left hemicolitis. Intervention 1: Intervention group: Ulcerative colitis patients in the intervention group will receive Mesalazine as standard treatment (3g/daily) combined with 300 mg/daily of Mebendazole orally. Intervention 2: Control group: This group will receive Mesalazine as standard treatment (3g/daily) plus placebo of Mebendazole. Yes - There is a plan to make this available What will be shared: We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study. When: Sharing of all collected de-identified participants data (IPD) will be started immediately after publication. To whom: All collected de-identified participants data (IPD) will be shared to people working either in academic institutions or business companies upon their request. Conditions: The collected de-identified participants data (IPD) will be only shared to those recipients who commit themselves to use them only for patients. They also should commit themselves to share these data with other organization only after asking permission from the original source. Where to obtain: Data/Documents will be obtainable by sending an e-mail to hasanianmehrm@mums.ac.ir How to obtain: The applicant who wish to have access to document/data files should send an e-mail to hasanianmehrm@mums.ac.ir commit him/herself to not to share these documents with others unless asking permission from the original source. Next, document/data will be sent to him/her by e-mail immediately. Comments:
public Seyed Mahdi Hassanian Mehr
Azadi Sq.
Mashhad Iran (Islamic Republic of) 9197985174 +98 51 3800 2353 hasanianmehrm@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Mahdi Hassanian Mehr
Azadi Sq.
Mashhad Iran (Islamic Republic of) 9197985174 +98 51 3800 2353 hasanianmehrm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Provide written documentation of informed consent to participate in the study. Male or female aged 18 to 60 years. Subjects with a confirmed diagnosis of moderate proctosigmoiditis and Left-sided colitis. Diagnosis established by endoscopy and histology. Participants have no proven current active gastrointestinal infection. 18 years 60 years Both Subjects with Crohn's disease or other types of colitis including Infectious, Radiation or Ischemic colitis. Allergy to Mesalamine or Mebendazole. Subjects who have a positive pregnancy test, or breast feeding. Subjects treated with immuno-modulatory drugs from two months before screening or receiving pro- or antibiotics from two weeks from screening. Patients who have already received metronidazole or Mebendazole for parasitic worm infection. Subjects with leukopenia, thrombocytopenia, neutropenia, Hb< 10 Subjects with Chronic Medical Conditions including heart diseases, lung diseases esp. Tuberculosis, Renal dysfunction, liver diseases, coagulation disorders, Drug abuse Patients with Ulcerative Proctitis. K51.3 K51.5 Ulcerative (chronic) rectosigmoiditis Left sided colitis Treatment - Drugs Placebo Intervention group: Ulcerative colitis patients in the intervention group will receive Mesalazine as standard treatment (3g/daily) combined with 300 mg/daily of Mebendazole orally. Control group: This group will receive Mesalazine as standard treatment (3g/daily) plus placebo of Mebendazole. Clinical Symptoms including weight loss, fever, bowel movement frequency, Stool consistency, Presence or absence of blood in feces, Mucus in feces. Timepoint: Before intervention, 1, 2 and 3 months after intervention. Method of measurement: Will be evaluated by physician. Laboratory Findings including measurement of Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, total and direct bilirubin, albumin, urea, creatinine, sodium, potassium, complete blood count, prothrombin time, partial thromboplastin time, international normalized ratio, total iron-binding capacity, iron, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin, and stool culture. Timepoint: Before intervention, 1, 2 and 3 months after intervention. Method of measurement: Standard laboratory methods. Histological findings including functional and cytological changes in crypts, presence of Paneth cells, alterations in mucus and sub-mucus, presence of crypt abscess, Cryptitis, reduction in intraepithelial muscins, presence of eosinophils in lamina propria, Basal Plasmacytosis and basal lymphoid aggregates. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Histology. Mashhad University of Medical Sciences Approved 2021-11-30 Ethics committee of Medical School, Mashhad University of Medical Sciences Medical School, Mashhad University of Medical Sciences, University campus, Azadi Square, Mashhad, Razavi Khorasan, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)