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IRCT20191026045244N3 IRCT 2022-04-11 Shahid Beheshti University of Medical Sciences The effect of Boron supplement on severity and duration of colic pain and the time of expulsion of urinary stone after Extracorporeal Shock Wave Lithotripsy The effect of Boron supplement on severity and duration of colic pain and the time of expulsion of urinary stone after Extracorporeal Shock Wave Lithotripsy compared to Tamsulosin 2018-04-05 anticipated 160 Complete https://irct.ir/trial/46805 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with the block size of four was used, to randomly allocate the patients to Boron and Tamsulosin groups and balance patient allocation between groups. Random Allocation software was used to generate random sequences. Given the random sequences generated, patients were divided into two groups, Blinding description: According to the apparent difference between tamsulosin (14 capsule) and boron (28 capsule) appearance and the numbers of drug needed in two groups, both participants and care provider not blinded during the study. But in the data analysis phase, data analyzer colleague was blinded regarding the type of drug prescribed in two patients group. 3 kidney stone. Intervention 1: Intervention group: Boron supplement capsule containing 88.5 mg sodium tetraborate decahydrate (Sigma, St. Louis, USA), i.e. (containing 10 mg Boron), and 221.5 mg lactose powder (as a filling material) will prescribe in patients (more than 18 years of old) after ESWL, two times a day for two weeks. Intervention 2: In control group, patients more than 18 years of old will treated with cap. Tamsulosin, 0.4 mg, rvery night for two weeks after ESWL. Yes - There is a plan to make this available What will be shared: The information about the type of treatment and the patients questionnaires will be available. When: The data could be available one year after the publication of the results. To whom: Data will be available for academic faculty members and researchers. Conditions: The control of the data and supplementary analyses of the data could be performed under copyright law. Where to obtain: Urology and Nephrology Research Center: Dr. Maryam Taheri: taheri233@yahoo.com/ Ms. Shabnam Golshan: +98-21-22567222 How to obtain: The applicant must submit a written request to the Urology and Nephrology Research Center. After the approval of the center and the PI of the proposal, the data will be available to the applicant. Comments:
public Maryam Taheri
No 103, 9th Boustan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 11666668111 +980212256722 taheri233@yahoo.com Shahid Beheshti University of Medical Sciences scientific Maryam Taheri
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 11666668111 +98212256722 taheri233@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) kidney stone patients referred to urinary stone Extracorporeal Shock Wave Lithotripsy of Labbafi nejad clinic 18 years no limit Both Urinary Tract Infection Chronic Kidney Disease Urinary Tract Surgery history (PCNL or open stone) contraindications to extracorporeal shockwave lithotripsy (ESWL) include: Acute urinary tract infection or urosepsis, Uncorrected bleeding disorders or coagulopathies, Pregnancy. History of Estrogen-Dependent Cancer (Breast, Endometrial and Ovarian) pregnancy or lactation N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: Boron supplement capsule containing 88.5 mg sodium tetraborate decahydrate (Sigma, St. Louis, USA), i.e. (containing 10 mg Boron), and 221.5 mg lactose powder (as a filling material) will prescribe in patients (more than 18 years of old) after ESWL, two times a day for two weeks. In control group, patients more than 18 years of old will treated with cap. Tamsulosin, 0.4 mg, rvery night for two weeks after ESWL. Stone size. Timepoint: Before ESWL and 14 days after ESWL. Method of measurement: The size of the stone in millimeters reported in the patient's ultrasound. Pain of expulsion. Timepoint: 14 days after ESWL. Method of measurement: Visual Analogue Scale. Time of expulsion. Timepoint: 14 days after ESWL. Method of measurement: Questionnaire. Auxillary treatment after ESWL. Timepoint: 14 days after ESWL. Method of measurement: Questionnaire. Drug complications. Timepoint: 14 days after ESWL. Method of measurement: Questionnaire. Number of pain medicines used. Timepoint: 14 days after ESWL. Method of measurement: questionnaire. Serum creatinine. Timepoint: Before ESWL, 14 days after ESWL. Method of measurement: Calorimetry. 46805 The effect of Boron supplement on severity and duration of colic pain and the time of stone expulsion of urinary stone after extra corporeal shock wave lithotripsy compared to Tamsulosin Shahid Beheshti University of Medical Sciences Approved 2017-08-10 Urology Nephrology Research Center Pasdaran Tehran Tehran Iran (Islamic Republic of)