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IRCT20230717058813N1 IRCT 2023-09-22 Shahid Beheshti University of Medical Sciences Comparing the effects of three therapeutic regimens prednisolone on platelet increase in patients with primary immune thrombocytopenic purpura Comparing the effects of three therapeutic regimens of oral prednisolone, intravenous methylprednisolone, and oral prednisolone plus recombinant human thrombopoietin on platelet increase in patients with primary immune thrombocytopenic purpura: a clinical trial study. 2023-10-23 anticipated 75 Complete https://irct.ir/trial/71792 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible subjects will be randomly assigned to one of the three groups receiving prednisolone alone, prednisolone + recombinant human thrombopoietin, and pulse methylprednisolone alone with a ratio of 1:1:1. The randomization method will be permuted block randomization, which will be done in 7 blocks of sizes 6, 9, 12, 15 until the sample size is exhausted using "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual). 3 primary immune thrombocytopenia purpura. Intervention 1: The first group: they will receive pulse methylprednisolone 2-3 mg/kg intravenously for 3 days every 2 weeks for 4 weeks until re-examination. Intervention 2: Control group: They will receive oral prednisolone tablets 1 mg/kg daily for 4-6 weeks until re-examination. Intervention 3: Intervention group: The analog of the human compound will receive 250 micrograms weekly subcutaneously for 4 weeks along with oral prednisolone tablets 0.5 mg/kg daily until re-examination. Yes - There is a plan to make this available What will be shared: All patient information will be entered into the database (Excel format) and after checking the the outliers terms and data cleaning, it will be prepared for statistical analysis. The final data file will be provided to the research unit of internal diseases department to conduct further studies. When: The access period starts 6 months after the results are published To whom: Researchers in academic institutions Conditions: If there is a positive outcome and to need for further studies in this field Where to obtain: Dr. Rehane Azimi Nobari-Imam Hossein Hospital- internal disease clinics How to obtain: using application form in research unit of hospital Comments:
public Reyhaneh Azimi Noubari
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 6314116177 +98 21 7343 3000 reyhaneh.azimi92@gmail.com Shahid Beheshti University of Medical Sciences scientific ّFarnaz Sabrian
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 6314116177 +98 21 7343 3000 dr.f.saberian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age of 18-60 years, having a normal spleen size suffering from Immune thrombocytopenia (ITP) 18 years 60 years Both history of chronic kidney diseases history of diabetes pregnant women or pregnancy during study history of secondary Immune thrombocytopenia (ITP) such as (Antiphospholipid syndrome, Myelodysplastic syndromes and vasculitis) patients under treatment with any drugs within 3-month before participating in study D68 Other coagulation defects Treatment - Drugs Treatment - Drugs Treatment - Drugs The first group: they will receive pulse methylprednisolone 2-3 mg/kg intravenously for 3 days every 2 weeks for 4 weeks until re-examination. Control group: They will receive oral prednisolone tablets 1 mg/kg daily for 4-6 weeks until re-examination. Intervention group: The analog of the human compound will receive 250 micrograms weekly subcutaneously for 4 weeks along with oral prednisolone tablets 0.5 mg/kg daily until re-examination. Platelet value in cell blood count test. Timepoint: Monthly. Method of measurement: Cell blood count test. Side effect of treatment with corticosteroids. Timepoint: Six-months after treatment. Method of measurement: Clinical visit. Shahid Beheshti University of Medical Sciences Approved 2023-07-01 Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran Tehran Iran (Islamic Republic of)