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IRCT20170225032756N2 IRCT 2019-11-05 Kermanshah University of Medical Sciences Evaluation of the effect of Palm kernel on size of kidney stones Evaluation of the efficacy of syrup of Palm kernel extract on stone size in patients with kidney stones 2018-04-21 anticipated 40 Complete https://irct.ir/trial/25438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Doubling Succession and Single Central, Randomization description: Randomization has been done in intervention and control groups by blocking method. Using the Excel sheet, we generated 20 groups with the block size of 2 people in each. Finally, we used the "Random" command to calculate the probability for each group. By sorting the probability, we selected 40 people, each allocated to intervention or those who received routine care, Blinding description: In this study, blind patients and researchers are kept. Each patient received a sealed envelop containing the relevant code for the type of intervention. Patients will be prescribed to receive whether palmicort syrup or routine treatment from the drugstore in the university clinic. Therefore, although, the nephrologist was not blind, the radiologist and other researchers from school of pharmacy were blind. In addition, as both groups received medication, they are not aware of whether they have received the routine care or new treatment. 2-3 kidney stone. Intervention 1: Intervention group : three times a day, every 8 hours, two tablespoons per meal or 5 cc Contains 4 gr active ingredient.Such patients receive low salt, low fat and low animal protein diet. Intervention 2: Control group: patients receive routing treatment for kidney stones by PI (nephrologist) including diuretics plus potasium citrate. Such patients receive low salt, low fat and low animal protein diet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There might be a plan to have a patent from this project.
public Marzieh Marami
School of Pharmacy. parastar Blv. Taghbostan. Kermanshah
Kermanshah Iran (Islamic Republic of) 6734667149 +98 83 3427 6480 marami.ent93@gmail.com School of Pharmacy scientific Dr Katayoon Etemadi
Sorzheh lizheh Blv. kermanshah
kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6489 marami.ent93@gmail.com Imam Reza Hospital Iran (Islamic Republic of) Age is over 18 years old. The patient signs the written consent and co-operates during the study. (In cases where the patient is illiterate, the consent form is read by the researcher and, if consent is given, to the patient.) stone size (less than 8 mm) number of stones between 1-5 location of stones in the kidneys in middle and/or upper calyx 18 years 60 years Both Pregnant patients and nursing mothers Patients who are compelled to take other medications that interfere with recent treatment Patients with clinical conditions who are at risk of serious health Patients with severe plant allergy N00-N99 xIv Treatment - Drugs Treatment - Drugs Intervention group : three times a day, every 8 hours, two tablespoons per meal or 5 cc Contains 4 gr active ingredient.Such patients receive low salt, low fat and low animal protein diet. Control group: patients receive routing treatment for kidney stones by PI (nephrologist) including diuretics plus potasium citrate. Such patients receive low salt, low fat and low animal protein diet. The size of kidney stones; size of kidney stones will be assessed by a radiologist using sonography. Timepoint: every month after starting the treatment until 3 months. Method of measurement: sonography. Expulsion of stone. Timepoint: once a month. Method of measurement: sonography. Hypertension: in those without history of high blood pressure, recording a blood pressure > 140/90. Timepoint: once a week after the starting of treatment. Method of measurement: measurement in physician office. Kermanshah University of Medical Sciences Approved 2016-07-13 Ethics Committee of Kermanshah University of Medical Sciences Building No 2, shahid beheshti Blv., Kermanshah University of Medical Sciences, Kermansshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)