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IRCT20180515039662N1 IRCT 2018-06-03 Ahvaz University of Medical Sciences The effect of N-acetylcysteine in the treatment of multiple sclerosis The effect of NAC in the treatment of patients with MS Effect of N-acetylcysteine on nitric oxide, oxidative stress biomarkers, depression and stress in patients with multiple sclerosis 2018-06-20 anticipated 60 Complete https://irct.ir/trial/31309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 60 people will be assigned by block randomization to two groups (30 in the intervention group and 30 in the placebo group) and 10 blocks will be created. Random numbers will be generated randomly by random allocation software, Blinding description: In this double blind study the jars containing the tablets will be the same and neither the patients nor researcher know which tablets are being received. In fact, a third person who knows the contents of the jars distributes them among the participants. The shape and size of the tablets are similar in both groups, while their content is different. 3 multiple sclerosis. Intervention 1: Intervention group: 30 ptients with multiple sclerosis will received 600 mg N-acetylcysteine effervescent tablet ( Zambon Pharma Co, Switzerland) twice daily within 12 hours (1200 mg daily) after being dissolved in warm water, for 60 days to be taken befor meals .to control the correct use of medicins, pills are given to patients every 2 weeks and the empty blisters of pills are collected and counted. If a patient did not consume more than 20% of tablets, he would be exclouded. Intervention 2: Control group: 30 ptients with multiple sclerosis will received one effervescent tablet (similar to 600 mg N-acetylcysteine effervescent tablet in terms of shape, colour and flavour) 2 times a day within 12 hours , after being dissolved in warm water, for 60 days to be taken after meals .the placebo will be produced at the Osveh Pharma Co, Iran with the fallowing formulation : micro-crystalline cellulose, corn starch, sorbitol and talk. to control the correct use of placebo, pills are given to patients every 2 weeks and the empty blisters of pills are collected and counted. If a patient did not consume more than 20% of tablets, he would be exclouded. No - There is not a plan to make this available Justification or reason for not sharing IPD is it is not the objective of this study.
public Golsa Khalatbari Mohseni
Faculty of Paramedicine, Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 6135815751 - Khalatbari.g@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr. Seyed Ahmad Hosseini
Paramedical School, Ahvaz Jundishapur University of Medical Sceinces, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 Seyedahmadhosseini@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with multiple sclerosis more than 2 years EDSS ≤ 4/5 Patients without current diagnosis of other inflammatory or autoimmune disease The age range is between 18-60 years Not taking depression or anxiety drugs Score of 10-30 (mild to moderate depression) from Beck Depression questionnaire in depression subscal and 15-25 (mild to moderate anxiety) from DASS21 questionnaire Tendency to participate in the study 18 years 60 years Both Clinical relapses within 3 months before or during the study Pregnancy and lactation Cardiovascular diseases Patients with blood pressure disorders Liver and kidney disease Bronchospasm, asthma and any respiratory failure Gastric ulcer Bleeding and impaired blood coagulation Those who are allergic to NAC and any combination it contains, Taking antioxidants or NAC over the past 60 days Smoking, alcohol or drugs abuse Stressful events during the study G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: 30 ptients with multiple sclerosis will received 600 mg N-acetylcysteine effervescent tablet ( Zambon Pharma Co, Switzerland) twice daily within 12 hours (1200 mg daily) after being dissolved in warm water, for 60 days to be taken befor meals .to control the correct use of medicins, pills are given to patients every 2 weeks and the empty blisters of pills are collected and counted. If a patient did not consume more than 20% of tablets, he would be exclouded. Control group: 30 ptients with multiple sclerosis will received one effervescent tablet (similar to 600 mg N-acetylcysteine effervescent tablet in terms of shape, colour and flavour) 2 times a day within 12 hours , after being dissolved in warm water, for 60 days to be taken after meals .the placebo will be produced at the Osveh Pharma Co, Iran with the fallowing formulation : micro-crystalline cellulose, corn starch, sorbitol and talk. to control the correct use of placebo, pills are given to patients every 2 weeks and the empty blisters of pills are collected and counted. If a patient did not consume more than 20% of tablets, he would be exclouded. Glutathione. Timepoint: The beginning of the study- The end of the study. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: The beginning of the study- The end of the study. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: The beginning of the study- The end of the study. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: The beginning of the study- The end of the study. Method of measurement: Spectrophotometry. Depression. Timepoint: The beginning of the study- The end of the study. Method of measurement: Beck questionnaire. Anxiety. Timepoint: The beginning of the study- The end of the study. Method of measurement: DASS 21 questionnaire. Body Mass Index. Timepoint: The beginning of the study- The end of the study. Method of measurement: Body weight / hight square (kg/m2). Dietary intake. Timepoint: The beginning of the study- The end of the study. Method of measurement: Three-day record. Ahvaz University of Medical Sciences Approved 2018-01-20 Ethics committee of Ahvaz University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)