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IRCT20190514043586N1 IRCT 2019-05-31 Shahid Beheshti University of Medical Sciences Effect of Acetaminophen on relief of bone pain due to PEG G-CSF comparison of the efficacy and complication of two medication regimen 'naproxen and loratadin’ with 'acetaminophen and loratadin' on relief of bone pain due to PEG G-csf in patients with solid tumors chemotherapy 2019-06-05 anticipated 200 Complete https://irct.ir/trial/39748 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected through available sampling method and are assigned to one of the two treatment groups using a simple accident method with blocks with block size 2. In this method, by referring each patient to the clinic, a card of size 2 will be taken randomly by the researcher and, depending on how the order is written on the card, the patient is assigned to group 1 or 2. The randomization unit here is the person participating in the study and there is no layer randomization. The randomization tool is a ready-made card that the researcher randomly takes them and ensures a random sequence of people entering the study. Hiding for the patient and researcher is not applicable here, but for the statistical analyst, hiding is carried out, and the data for the two groups of patients are presented to him as groups A and B. 3 Bone Pain Due to PEG G-CSF. Intervention 1: Intervention group1:Tab Acetaminophene 500 mg orally every 6 hours +Tab Loratadine 10 mg orally daily, from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief. Intervention 2: Intervention group2: Tab Naproxene 500 mg orally every 12 hours +Tab Loratadine 10 mg orally daily,from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief. Yes - There is a plan to make this available What will be shared: No more information When: One Year After Publish of Rsults To whom: Researchers working in academic institutions Conditions: For studying and treating patients Where to obtain: E-mail:dr.saeid.noorani@gmail.com How to obtain: Sign in to the clinical trial site and search for keywords Comments:
public Seyed Amir Sheykholeslami
South Shahid Madani Ave., Emam Hossin hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 amirsheikholeslami@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Amir Sheykholeslami
South Shahid Madani Ave., Emam Hossin hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 amirsheikholeslami@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People with Solid Tumor or Lymphoma who receive PEG G-CSF due to neutropenia after chemotherapy no limit no limit Both Bone matastasis PFS more than 2 Osteomalacia proven with laboratory tests CKD or ESRD Active Rheumatologic disease Uncontrolled Diabetes or Thyroid disease Patients receiving chemotherapy drugs that have bone pain are a high prevalence of 10% (TAXAN family, bisphosphonate ...) Pathologic fracture or fracture due to any reason Naproxen use contraindication Vitamin D level less than 20 Paget disease Hyperparathyroidism People who have had a score of over 6 in the bone pain score since the beginning of the project Liver disease History of Cardiac Arrhythmia Patient who have not compliance for completing pain questionnaire C83 Non-follicular lymphoma Treatment - Drugs Treatment - Drugs Intervention group1:Tab Acetaminophene 500 mg orally every 6 hours +Tab Loratadine 10 mg orally daily, from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief. Intervention group2: Tab Naproxene 500 mg orally every 12 hours +Tab Loratadine 10 mg orally daily,from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief. Pain Score in Visual Analogue Scale(VAS) questionnaire. Timepoint: Day 0; One day after the end of first and third course of chemotherapy. Method of measurement: Visual Analogue Scale questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-04-14 Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medical Scieences 13th floor, block A, Central staff of Ministry of Health and Medical Education, Simaye Iran Ave., between south Falamak and Zarafshan AVE., Qods(gharb) town Tehran Tehran Iran (Islamic Republic of)