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IRCT20241219064101N2 IRCT 2025-03-11 Nooshin Shahd Urmia Company The evaluation of four plants extract effectiveness on renal stone passage The evaluation of four plants extract effectiveness on renal stone passage in patients whom underwent extracorporeal shockwave lithotripsy, A double blind randomized clinical trial 2025-03-10 anticipated 62 Complete https://irct.ir/trial/81244 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: They are randomly divided into two groups using the envelope method, which is provided to the patients by the secretary of the stone crusher department of Meybod Hospital. In order to randomly allocate eligible patients into two groups, we consider patients numbered 1 to 62 in the order of their referral, and then, using the Random Allocation Version 2 software, a random sequence is generated and individuals are placed in two intervention or control groups (A, B). The method of generating random codes is simple random. In order to blind the random allocation, the random allocation list is provided to another person who is outside the study, and the type of intervention is asked from this person based on the list by text message or phone, Blinding description: Those who have been kept blind include: 1) the participants who are the same patients with kidney stones who are candidates for extra-organ stone crushing in the Stone Crushing Center of Imam Jafar Sadegh Meybod Hospital were included in the study under the conditions of entry and with consent. 2) The evaluator is an experienced and single radiologist who subjects all participants to kidney ultrasound after 40 days. 3 A study of patients with kidney stones who are candidates for extracorporeal lithotripsy. Intervention 1: Intervention group: this group, which includes 31 eligible patients, will be given antibiotics, painkillers, and extracts of four plants (nettle, thistle, horsetail, celery), and patients are advised to take the prescribed medications according to the instructions of the Urmia Farteb Company for forty days (10 cc, three times a day). Intervention 2: Control group: This group, which includes 31 eligible patients, will be given a placebo, which is also prepared by Urmia Farteb Company, which is mint extract, and is given to 31 patients with exactly the same packaging, and patients are advised to take the prescribed medications according to the instructions of the Urmia Farteb Company for forty days (10 cc, three times a day). Yes - There is a plan to make this available What will be shared: A part of the data such as the information related to the main outcome or the like can be shared. When: Access to study documentation after results are published To whom: It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them. Conditions: For secondary studies Where to obtain: Traditional Medicine Research Center, Yazd Shahid Sadoughi University of Medical Sciences How to obtain: The request sent will be reviewed by the members of the center. If the members agree, they will be notified. Comments: There is no further information.
public Amirhossein Rahavian
Enghelab avenue
Yazd Iran (Islamic Republic of) 8918815484 +98 35 3525 0480 amirrahavian@yahoo.com Yazd Shahid Sadoughi University of Medical Sciences Campus scientific Amirhossein Rahavian
Enghelab Avenue
Yazd Iran (Islamic Republic of) 8918815484 +98 35 3525 0480 amirrahavian@yahoo.com Yazd Shahid Sadoughi University of Medical Sciences Campus Iran (Islamic Republic of) Patients with kidney stones and candidates for extracorporeal shockwave lithotripsy The Hounsfield unit of the stone< 1000 The age>18 years The distance between the stone and the skin surface< 10 cm The stone size is between 1-2 cm 18 years no limit Both Febrile patients or active UTI History of renal lithotripsy and DJ insertion Not consenting to participate in the study Any complications during or after ESWL Failure to comply their post-lithotripsy follow-up. Any anatomical abnormalities in the kidney undergoing lithotripsy History of CT Scan for any reason in the past year Pregnant women and children. Consumption of antiplatelet and anticoagulant drugs Consumption of other drugs due to any underlying disease. History of allergy to the ingredients of the four-herb extract drug N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: this group, which includes 31 eligible patients, will be given antibiotics, painkillers, and extracts of four plants (nettle, thistle, horsetail, celery), and patients are advised to take the prescribed medications according to the instructions of the Urmia Farteb Company for forty days (10 cc, three times a day). Control group: This group, which includes 31 eligible patients, will be given a placebo, which is also prepared by Urmia Farteb Company, which is mint extract, and is given to 31 patients with exactly the same packaging, and patients are advised to take the prescribed medications according to the instructions of the Urmia Farteb Company for forty days (10 cc, three times a day). Percentage of people who completely passed kidney stones after ESWL. Timepoint: forty days after lithotripsy and drug consumption. Method of measurement: Before stone crushing, we subject all patients to a CT scan of the abdomen and pelvis without injection to obtain accurate information about the stone, and we request a urine culture test for all patients to detect a possible urinary tract infection. Then the patients are subjected to stone crushing by an experienced personnel in the field of extracorporeal stone crushing and by a single device.40 days after stone crushing, patients are subjected to kidney ultrasound by an experienced radiologist and the presence or absence of stones and the size of stone remains are checked. Stone location. Timepoint: Before lithotripsy and forty days after lithotripsy and drug consumption. Method of measurement: Before lithotripsy, we subject all patients to a CT scan of the abdomen and pelvis without injection to obtain accurate information about the stone, and we request a urine culture test for all patients to detect a possible urinary tract infection. Then the patients are subjected to stone crushing by an experienced personnel in the field of extracorporeal stone crushing and by a single device.40 days after stone crushing, patients are subjected to kidney ultrasound by an experienced radiologist and the presence or absence of stones and the size of stone remains are checked. Stone size. Timepoint: Before lithotripsy and forty days after lithotripsy and drug consumption. Method of measurement: We perform a non-injection CT scan of the abdomen and pelvis before lithotripsy to obtain accurate information about the stone, and we request a urine culture test for all patients to detect possible urinary tract infection. Then, patients undergo lithotripsy by an experienced staff in the field of extracorporeal lithotripsy using a single device. Patients undergo renal ultrasound 40 days after lithotripsy by an experienced radiologist and the unit, and the presence or absence of stones and the size of the stone remnants are examined. Nooshin Shahd Urmia Company Approved 2023-10-14 Research Ethics Working Group/Committee of Shahid Dr. Rahmanmun Hospital, Shahid Sadoughi University Enghelab Avenue Yazd Yazd Iran (Islamic Republic of)