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IRCT20221225056918N1 IRCT 2023-02-18 Hamedan University of Medical Sciences The effect of caltrop extract on renal stones The effect of caltrop (Tribulus terristris) aqueous extract on 6-10 mm renal stones: a double blind randomized clinical trial 2023-03-06 anticipated 64 Complete https://irct.ir/trial/67730 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study population includes 64 patient with kidney stone disease (stone size between 6-10 millimeters). Patients will be divided into control and intervention group by chance (32 patients in each group). The study is a double blind randomized clinical trial during 8 weeks. Initially the size and position of stones will be obtained by sonography or CT-Scan. At the end of study, sonography or CT-scan will be repeated. The results of examining size, number and location of stones in two groups will be compared, Randomization description: Randomization will do in the intervention and control groups by blocking method. Using the Excel sheet, we generated 32 group with the block size of 2 people in each. Finally, we use the "Random" command to calculate the probability for each group. By sorting the probability, we will select 64 people, each allocate to intervention or placebo, Blinding description: In this study, patients and researchers are kept blind. Each patient will receive a sealed envelop containing the relevant code for the type of intervention. Patients will be prescribed to receive whether A or B pack. Therefore, although, the pharmacologist is not blind, the radiologist and other researchers from medical school will be blind. In addition, as both groups will receive medication, they are not aware of whether they have receive the placebo or new treatment. 3 urolithiasis. Intervention 1: Intervention group: Volunteers will take 10cc of caltrop syrup twice a day during two months. Intervention 2: Control group: Volunteers will take 10cc of placebo syrup twice a day during two months. 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 No more information
public Mehdi Biglarkhani
Shahid fahmideh Blvd., Pajoohesh Sq.
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3131 0000 mahdibiglarkhani@gmail.com Hamedan University of Medical Sciences scientific Mehdi Biglarkhani
Shahid Fahmideh Blvd., Pajoohesh Sq.
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3131 0000 mahdibiglarkhani@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Renal stones between 6-10 mm (kidney sonography or spiral CT without contrast) Renal stones without simultaneous symptoms ( uncontrollable pain and nausea and vomiting ) or referral pain Number of stones: between 1-3 stones The stones localize upper, middle and lower calyxes Agreement of participant to inform consent and signing itʼs written form before recruiting in the study. Age of participant between 18-60 yr both gender The participant don't use other herbal or chemical drugs that effect on renal stones (allopurinol, indinavir, ). Normal LFT (SGOT,SGPT, Alkaline Phosphatase), Normal KFT(BUN, Cr) 18 years 60 years Both Consumption other types of chemical or herbal drugs except those prescribed in this study; History of significant problems (diabetes mellitus, renal dysfunctions, hepatic dysfunctions and peptic ulcer) other procedures or emergency interventions Affecting by urinary stone complications (any grade of hydro-nephrosis and urinary tract infectious) Subjects intending to withdraw at any time during the course of study Pregnancy; Lactating sensitivity to Caltrop Treatment - Drugs Placebo Intervention group: Volunteers will take 10cc of caltrop syrup twice a day during two months. Control group: Volunteers will take 10cc of placebo syrup twice a day during two months. Size of renal stones. Timepoint: Before intervention and two months after intervention. Method of measurement: Sonography or CT-scan without contrast. Location of renal stones. Timepoint: Before inter vention and two months after intervention. Method of measurement: Sonography or CT-scan without contrast. Number of stones. Timepoint: Before inter vention and two months after intervention. Method of measurement: Sonography or CT-scan without contrast. Hamedan University of Medical Sciences Approved 2022-12-24 Ethics committee of Hamedan medical university Shahid fahmideh Ave., Pajoohesh Sq. Hamedan Hamadan Iran (Islamic Republic of)