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IRCT20200112046087N2 IRCT 2020-05-18 Shahid Beheshti Faculty of Traditional Medicine Evaluation of the efficacy of natural product with placebo on renal stone therapy Evaluating the effect of selected natural product (Bore armani and Raphanus niger Mill. combination/mixture) compared to placebo in the treatment of kidney stones, a double-blind study 2020-07-22 anticipated 70 Complete https://irct.ir/trial/45920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization. Block randomization is used with 4 blocks, which will be used to generate random sequences using Random Allocation software. Due to randomly generated sequences, patients enter the control and intervention groups. As these patients will be referred by the treating physician to the planter, a list of the names of the nominees will be provided with a row number, and a coin will be used to decide whether or not to assign the numbers to the intervention group, Blinding description: In this plan, the drug and placebo are prepared by the pharmacist. After preparing the drug, the pharmacist will insert a specific code of the medicine on the bottle. These codes are only available to the pharmacist, and no one knows what kind of medicine (medicine or placebo) until the end of the study. The shape and size of all drugs are the same and indistinguishable. Therefore, the project implementer uses the drugs randomly for each patient. At the end of the study, after collecting the data, with the help of a pharmacist, the codes related to the drug and the drug facade are distinguished from each other, but information about the drug and placebo is hidden for the analyzer. Only at the end of the study, The codes are decrypted and the necessary information is provided to the executor. 3 kidney stone. Intervention 1: Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 oral capsules 3 times a day. This capsule contains the500 mg powder of blue horseradish extract and the Armenian borax powder in equal proportions. The drug was previously developed under a separate approved plan. In that plan, toxicological tests, etc., have been performed on the Armenian boulder used in this compound, and its safety has been evaluated. The intervention lasts one week. Intervention 2: Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 placebo capsules 3 times, before each meal for one week. The prescribed capsule in the control group contains 500 mg of powdered dry Sangag bread. Which is packaged in exactly the same way as the intervention capsules. Yes - There is a plan to make this available What will be shared: Information on changes in urinary, blood, and sonographic parameters of patients When: 1401 To whom: Researchers working in academic and academic institutions Conditions: Request a printed article and oral explanations and guidance by email and academic identity Where to obtain: In charge of Dr. Reza Ilkhani's plan. Email: ilkhanir@sbmu.ac.ir How to obtain: Email information to Dr. Ilkhani will be provided if he so desires and with the research assistant of Shahid Beheshti Traditional School of Medicine approve Comments:
public Reza ilkhani
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 ilkhanir@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza Ilkhani
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 ilkhanir@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Kidney or ureteral stones less than 10 mm in size, according to ultrasound reports Pregnancy and lactation in women No kidney tumors Lack of emergency conditions in the patient No insulin-dependent diabetes Not taking any herbal medicine for kidney stones Blood creatinine less than 1.4 mg/dl 20-60 years 20 years 60 years Both Severe urinary tract infection Emergency cases of kidney stones or the need for surgical intervention N20.0 Calculus of kidney Treatment - Drugs Placebo Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 oral capsules 3 times a day. This capsule contains the500 mg powder of blue horseradish extract and the Armenian borax powder in equal proportions. The drug was previously developed under a separate approved plan. In that plan, toxicological tests, etc., have been performed on the Armenian boulder used in this compound, and its safety has been evaluated. The intervention lasts one week. Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 placebo capsules 3 times, before each meal for one week. The prescribed capsule in the control group contains 500 mg of powdered dry Sangag bread. Which is packaged in exactly the same way as the intervention capsules The size of the stone. Timepoint: Before entering the study (before starting the drug) and 8 days after starting the drug. Method of measurement: Kidney ultrasound. Shahid Beheshti Faculty of Traditional Medicine Approved 2020-02-09 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Daneshju Blv. Tehran Tehran Iran (Islamic Republic of)