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IRCT20190528043734N1 IRCT 2019-09-06 Shahid Beheshti University of Medical Sciences Studying the effect of N-acetyl cysteine in cirrosis Studying the effect of N-acetyl cysteine in cirrhotic patients 2019-09-11 anticipated 80 Complete https://irct.ir/trial/41196 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization, individually, will be performed using a sealed envelope by placing the patient numbers of 1 to 80 in two groups or the same in two envelopes. Only the researcher knows which group the envelopes and numbers belong to and allocation concealment will be double blind, Blinding description: Participants will be aware of the effective intervention on health but without awareness of its type. The physician and researcher and data collector will be kept blind to the type of the intervention. The data analyzer is also kept blind. 3 cirrhosis. Intervention 1: Intervention group: patients will receive 600 mg tablets of NAC twice a day for 6 months. Intervention 2: Control group: Patients will receive placebo tablets completely similar to NAC tablets twice a day for 6 months. 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 No more information.
public Maryam Masoumi
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 maryammasoumii666@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam Masoumi
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 maryammasoumii666@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Child suffering class A or B of cirrhosis Patients with score of 5-9 of child pugh score 18 years 70 years Both Patient with class c of child pugh score K74 Cirrhosis Treatment - Drugs Placebo Intervention group: patients will receive 600 mg tablets of NAC twice a day for 6 months Control group: Patients will receive placebo tablets completely similar to NAC tablets twice a day for 6 months Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Child-Puff score system with scores categorized as A, B and C. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: MELD scoring system based on bilirubin and creatinine serum levels. Kidney function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Creatinine level due to lab results. Kidney function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Urea level due to lab results. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Aspartate Transaminase (AST) level due to lab results. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Alanine Aminotransferase (ALT) level due to lab results. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Total bilirubin level due to lab results. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Albumin level due to lab results. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Prothrombin time (PT) level due to lab resulst. Liver function. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: International Normalized Ratio (INR) level due to lab resulst. Blood parameter. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Hemoglobin level due to lab results. Blood parameter. Timepoint: At the baseline and 6 months after starting N-acetylcycteine. Method of measurement: Platelet number due to lab results. Shahid Beheshti University of Medical Sciences Approved 2019-02-03 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)