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IRCT20140804018677N12 IRCT 2021-08-17 Shahid Beheshti University of Medical Sciences Rudioretic supplement and kidney stone Evaluation of the effect of Rudioretic supplement comparing to placebo on renal stone: A randomized clinical trial 2021-09-11 anticipated 160 Complete https://irct.ir/trial/58039 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Block Randomization method is used to randomize the patients. For randomization, we will visit www.sealedenvelope.com and use the randomization tab to make a list considering the number of intervention groups, sample size, block size. Block size will be 8 (AABBCCDD and other compositions). The prepared list that contains the pattern of patient allocation will be obtained and used. This site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 160 patients: 40 patients in the intervention group with capsule (A), 40 patients in the intervention group with drop (B), 40 patients in the control group with capsule (C), and patients in the control group with drop. blocks will be randomly Then 160 pockets (40 pockets containing paper containing A, 40 containing B, 40 pockets containing C, and 40 pockets containing D) will be prepared based on sample size. According to a list of blocks, a trained person will be set the row of pockets. After the admission of each patient will be given a pocket and assigned to Group A (intervention 1) or B (intervention 2) or C (control group 1) or D (control group 2). The sampling process will be performed sequentially until the end of the completion of the sample size. 3 Kidney stone. Intervention 1: Supplement group A: will receive 2 capsules of Rudioretic every 8 hours with empty stomach for 6 weeks. Each capsule contain 500 mg of Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L. Intervention 2: Supplement group B: will receive 40 drops of Rudioretic every 8 hours with empty stomach for 6 weeks. Rudioretic contain Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L. Intervention 3: Placebo group C: will receive 2 capsules of placebo contains maltodextrine every 8 hours for 6 weeks . Intervention 4: Placebo group D: will receive 40 drops of placebo contains maltodextrine every 8 hours for 6 weeks . Yes - There is a plan to make this available What will be shared: All data would be available to public When: Starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: Sending email Comments:
public Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosed with a kidney stone without hydronephrosis and no need for medication Age between 18-45 years Willing to participate in the study 18 years 45 years Both Pregnancy or lactation Having known heart disease Receiving drugs that affect kidney stones N20.0 Calculus of kidney Treatment - Other Treatment - Other Placebo Placebo Supplement group A: will receive 2 capsules of Rudioretic every 8 hours with empty stomach for 6 weeks. Each capsule contain 500 mg of Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L. Supplement group B: will receive 40 drops of Rudioretic every 8 hours with empty stomach for 6 weeks. Rudioretic contain Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L. Placebo group C: will receive 2 capsules of placebo contains maltodextrine every 8 hours for 6 weeks . Placebo group D: will receive 40 drops of placebo contains maltodextrine every 8 hours for 6 weeks . Number of excreted kidney stone. Timepoint: Start of intervention and a month later. Method of measurement: Ultrasonography and blood and urine tests. Stone size. Timepoint: Start of intervention and a month later. Method of measurement: Sonography. Urine volume 24 h. Timepoint: Start of intervention and a month later. Method of measurement: Urine 24 h test by BT-1500 autoanalyser. Creatinine in urine 24h. Timepoint: Start of intervention and a month later. Method of measurement: Urine 24h test by Pars Azmoon kit. Oxalate in urine 24 h. Timepoint: Start of intervention and a month later. Method of measurement: urine 24 h test by Darmankau kit. Citrate in urine 24 h. Timepoint: Start of intervention and a month later. Method of measurement: urine 24 h test by Darmankau kit. Uric acid in urine 24 h. Timepoint: Start of intervention and a month later. Method of measurement: urine 24h test by Pars Azmoon kit. Urine specific gravity. Timepoint: Start of intervention and a month later. Method of measurement: Urinalysis by BT-1500 autoanalyser. Shahid Beheshti University of Medical Sciences Approved 2019-02-17 Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)