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IRCT20180501039499N1 IRCT 2018-08-12 Arak University of Medical Sciences Comparison of the Effects of Oral Sirolimus and Oral Cyclosporine on the Thrombocytopenic Chronic Purpura Comparison the efficacy and safety of Oral Sirolimus and oral cyclosporine in the chronic thrombocytopenic purpura immune in children 2018-10-17 anticipated 60 Complete https://irct.ir/trial/32366 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization was done using permuted blocks of four different block sizes 2,4,6,8; then study subjects were separated 1:1 to Cyclosporine and sirolimos groups, Blinding description: After obtaining informed consent, patients will be randomly assigned to one of the two treatment groups(sirolimus or cyclosporine) and patients will be unaware of the type of treatment group they are in. 3 Idiopathic thrombocytopenic purpura. Intervention 1: Control group: Patients in this group will receive oral cyclosporine 5 mg / kg / day twice a day for 6 months. Intervention 2: Intervention group: Receiving oral Sirolimus in this group is as follows, , the first day of the loading dose is 6 mg and from the second day, 2 mg per m2 of body weight per day (children over 40 kg) and or the first day of the loading dose is 3 mg and from the second day, 1 mg per m2 of body weight per day (children over 40 kg) for 6 months. Yes - There is a plan to make this available What will be shared: Informed consent When: 2018/07/07 To whom: It's free to the public Conditions: It's free to the public Where to obtain: Call How to obtain: 48 hours after the call Comments: 48 hours after the call
public Morteza MousaviHasanzadeh
Amirkabir Hospital, Khoram street
Arak Iran (Islamic Republic of) 38146-7-5999 +98 86 3322 0099 Morteza.mousavi1993@gmail.com Arak University of Medical Sciences scientific aziz eghbali
Amirkabir Hospital, Khoram AVe
Arak Iran (Islamic Republic of) 38146-7-5999 +98 86 3322 0099 aziz_eghbali@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Children aged 5 to 15 years with chronic idiopathic thrombocytopenic purpura Not having any other blood diseases Parental informed consent 5 years 15 years Both Increase BUN / CR or decrease GFR by less than 50 ml / day. Seizure Allergic reaction Oral drug intolerance No response to drug treatment after 3 months. D69.3 Immune thrombocytopenic purpura Treatment - Drugs Treatment - Drugs Control group: Patients in this group will receive oral cyclosporine 5 mg / kg / day twice a day for 6 months Intervention group: Receiving oral Sirolimus in this group is as follows, , the first day of the loading dose is 6 mg and from the second day, 2 mg per m2 of body weight per day (children over 40 kg) and or the first day of the loading dose is 3 mg and from the second day, 1 mg per m2 of body weight per day (children over 40 kg) for 6 months. Idiopathic thrombocytopenic purpura. Timepoint: Platelet measurement at the beginning of the study, months 1 to 6 after treatment. Method of measurement: The number of platelets is measured by using the Cell counter sysmax device. Arak University of Medical Sciences Approved 2018-07-07 Ethics committee of Arak University of Medical Sciences ََAmir kabir hospital, Khoram AVe, Arak Town Arak Markazi Iran (Islamic Republic of)