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IRCT20211123053165N1 IRCT 2021-12-22 Esfahan University of Medical Sciences Effect of N-Acetyl-cysteine On platelet Engraftment post Auto-HSCT Effect of N Acetyl cysteine on platelet engraftment post autologous bone marrow transplantation in comparison to control group 2021-12-22 anticipated 30 Complete https://irct.ir/trial/60413 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After calculating sample size, because there are intervention and control groups, these data is inserted in online Random Allocation software.The software randomly give two sequences of number, which distributed in two groups.According to entrance of every patient,assigns a number to each volunteer.Then regard to the number is belonged to which group , patients will be in control or intervention group, Blinding description: The company that produced drug and placebo, packed them in different color boxes and with them send us a closed letter in which explain each color is related to drug or placebo. We will open this letter at the end of study, when the data analyzed.So participants, investigators, health care providers,information gathering responsible and Analyzer have been blinded. 3 Condition 1: MULTIPLE MYELOMA. Condition 2: LYMPHOMA. Condition 3: Auto-Hsct. Intervention 1: Intervention group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received N-Acetyl cysteine tablets, in form of 200mg tablets which produced by Toliddarou pharmaceutical company, 400 mg every 8 hours(21 days). Intervention 2: Control group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received Placebo tablets, in the same form as control group, which produced by Toliddarou pharmaceutical company, two tablets every 8 hours(21 days). Yes - There is a plan to make this available What will be shared: only data related to main outcome will be shared. When: 3months post published results To whom: Academic Researchers Conditions: Analyzing the revealed data is not allowed. Where to obtain: Rasoul Ghasemian, Isfahan Medical university rasoolqasemian@yahoo.com How to obtain: after e-mailing us, we send data. Comments:
public Rasoul Ghasemian
No 20, Farhangian A, Irajmirza Ave,Kahran Ave, Golzar street
Esfahan Iran (Islamic Republic of) 8154916877 +98 31 3226 1922 rasoolqasemian@yahoo.com Esfahan University of Medical Sciences scientific Mohamadsaleh Peikar
Motahari street
esfahan Iran (Islamic Republic of) 8174673461 +98 31 3235 5125 mspeikar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with Multiple Myeloma who are eligible for Auto-HSCT Patients with Lymphoma who are eligible for Auto-HSCT 16 years 65 years Both History Of Allergic Reaction to N-Acetyl cysteine or its ingredients History of Bronchial Asthma C90.0 C81 Multiple myeloma Hodgkin lymphoma Treatment - Drugs Placebo Intervention group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received N-Acetyl cysteine tablets, in form of 200mg tablets which produced by Toliddarou pharmaceutical company, 400 mg every 8 hours(21 days). Control group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received Placebo tablets, in the same form as control group, which produced by Toliddarou pharmaceutical company, two tablets every 8 hours(21 days). Median Platelet number post auto-Hsct. Timepoint: During admition daily then weekly for at least 3 weeks. Method of measurement: complete blood count test. Esfahan University of Medical Sciences Approved 2021-11-12 Ethics committee of Isfahan University of Medical Science No 20, Farhangian A, Irajmirza Alley, Kahran Alley, North Golzar Esfahan Isfehan Iran (Islamic Republic of)