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IRCT20190701044062N11 IRCT 2022-09-08 Tabriz University of Medical Sciences Evaluation of Sodium Pentaborate on Left Side Ulcerative Colitis Evaluation of Sodium Pentaborate Enema on Left Side Ulcerative Colitis Clinical Signs and Colonoscopic Findings 2022-08-23 anticipated 60 Complete https://irct.ir/trial/59285 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is done using the simple randomization method using the codes provided by Graphpad software. The drug and placebo codes are also received using this software and specified as solutions A and B, and then will be presented to the patients by the secretary. Until the end of the study, random numbers and codes will only be available to the supervisor head nurse who is not present in other parts of the study. The patients, the secretary providing the drugs, the specialist evaluating the severity of the disease, and the statistical analyst are blinded to the allocation of people to the study groups until the end of the study, and thus concealment is done in randomization, Blinding description: Patients and specialists evaluating the severity of the disease and the statistical analyst will be blind to the allocation of individuals to study groups until the end of the study. Design, color, appearance and all other properties of drug and placebo are same for blinding the study for individuals too. 3 Ulcerative Colitis. Intervention 1: Intervention group: Patients in the intervention group are prescribed 2 grams of Oral tablet of mesalazine daily and a Sodium Pentaborate 3% rectal enema gel(Satin Tan Kimia company product) in the amount of 100cc daily for 4 weeks. Also at the beginning of the trial for each patient, a training class will be held to train the patient about the process of study. Intervention 2: Control group: Patients in the control group are prescribed Oral tablet of mesalazine 2 g daily and a rectal enema gel without Sodium Pentaborate as a placebo(Satin Tan Kimia company product) in the amount of 100 cc daily for 4 weeks. Also at the beginning of the trial for each patient, a training class will be held to train the patient about the process of study. 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 Data is not ready yet.
public Manouchehr Khoshbaten
Imam Reza Hospital Clinic, Golgasht St.
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Imam Reza Hospital Clinic, Golgasht St.
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) All left side ulcerative colitis patients who are between 18 and 65 years old 18 years 65 years Both Patients who can't endure enema Patients with other diseases as : Crohn's disease, Intermediate Colitis, CMV, Pseudomemberanous Colitis, Heart Failure, CRF, PSC Pregnant or breastfeeding patients K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: Patients in the intervention group are prescribed 2 grams of Oral tablet of mesalazine daily and a Sodium Pentaborate 3% rectal enema gel(Satin Tan Kimia company product) in the amount of 100cc daily for 4 weeks. Also at the beginning of the trial for each patient, a training class will be held to train the patient about the process of study. Control group: Patients in the control group are prescribed Oral tablet of mesalazine 2 g daily and a rectal enema gel without Sodium Pentaborate as a placebo(Satin Tan Kimia company product) in the amount of 100 cc daily for 4 weeks. Also at the beginning of the trial for each patient, a training class will be held to train the patient about the process of study. Activity of disease based on Mayo score. Timepoint: Assessment of disease activity at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: Mayo Score. Frequency of daily defecation. Timepoint: Assessment of daily defecation frequency at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency of daily defecation and using it in Mayo Score scale. Rectal Bleeding. Timepoint: Assessment of rectal bleeding at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency and amount of of rectal bleeding and using it in Mayo Score scale. Endoscopic findings. Timepoint: Assessment of endoscopic findings at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By direct vision of endoscopist based on Endoscopic Sub Score in Mayo Score scale. Tabriz University of Medical Sciences Approved 2021-11-23 Ethics Committee of Tabriz University of Medical Sciences The central building of Tabriz University of Medical Science,Golgasht St.,Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)