]>
IRCT20200408046990N9 IRCT 2022-04-06 Mashhad University of Medical Sciences Protective effect of oral nano-silymarin on vancomycin-induced nephrotoxicity Evaluation of protective effect of nano-silymarin oral formulation on vancomycin-induced nephrotoxicity 2021-12-20 anticipated 60 Complete https://irct.ir/trial/60761 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 15 blocks from Quadruple blocks and finally 60 patients will enter the study. Allocation concealment method: Use of the central service, which consists of people who work in the center and have no knowledge of the researchers and will make a secret allocation for the research. In this method, based on the blocks created in the randomization method, a code is considered for each patient, which will be provided to the researcher at the time of patient admission by a person who has no knowledge of the process of studies and statistical analysis, Blinding description: The capsules will be identified by the number 1-60, which are based on a random list prepared from randomization.com, belonging to the drug or placebo group, and are placed in cans by the manufacturer according to the randomization list prepared. Physicians, patients, and the person analyzing the results will remain unaware of the type of formulation until the work is completed. Patients receive one of the medicine containers with the number 1-60 from the clinical pharmacy resident, respectively. The list will be decrypted when completed. If a new drug, whether related to cancer or not is started for the patient he or she will inform the physician. 3 نفروتوکسیسیته وانکومایسین. Intervention 1: Intervention group: silymarin softgel prepared by Exir nano Sina Inc. Company twice a day (after breakfast and dinner) for 14 days or until vancomycin is discontinued (There is no routine preventive measure). Intervention 2: Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast and dinner) for 14 days or until vancomycin is discontinued. (There is no routine preventive measure). 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 is no more information
public Vahid Soleimani
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9415945344 +98 51 3180 1588 soleimaniv981@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9415945344 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 60 Take vancomycin at a dose of 15-20 mg / kg two to three times a day for at least one week Signing a written consent by the patient Creatinine clearance greater than 90 ml/min based on Cockcroft-Gault formula 18 years 60 years Both Underlying renal impairment such as glomerulonephritis, polycystic kidney disease, renal stone, interstitial nephritis, renal artery stenosis and renal carcinoma Receive nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, tacrolimus and furosemide, etc. simultaneously History of allergy to products containing silymarin History of acute kidney injury Pregnancy and lactation Consumption of vitamin and herbal antioxidant supplements such as vitamins C and E or curcumin and ... Prevention Prevention Intervention group: silymarin softgel prepared by Exir nano Sina Inc. Company twice a day (after breakfast and dinner) for 14 days or until vancomycin is discontinued (There is no routine preventive measure). Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast and dinner) for 14 days or until vancomycin is discontinued. (There is no routine preventive measure). Incidence of vancomycin nephrotoxicity (increase of 0.3 mg/dl for two consecutive days). Timepoint: At baseline (before intervention) and on days 3, 7, 10 and day 14. Method of measurement: Serum creatinine level is measured by Jaffe method. Serum creatinine and BUN levels. Timepoint: At baseline (before intervention) and on days 3, 7, 10 and day 14. Method of measurement: Serum creatinine level is measured by Jaffe method. Serum cystatin C levels. Timepoint: Serum levels of cystatin C on days 3 and 7. Method of measurement: turbidimetry method. Time of onset of nephrotoxicity. Timepoint: Days 0, 3, 7, 10, 14, 21 after starting vancomycin. Method of measurement: For nephrotoxicity, serum creatinine level is measured by Jaffe method and serum cystatin C level is measured by turbidometry method. Duration of hospitalization. Timepoint: Daily during treatment. Method of measurement: clinical evaluation of the physician will be performed during treatment. Occurrence of other side effects of vancomycin including Red Man syndrome and hematological complications, etc., as well as occurrence of silymarin side effects such as gastrointestinal complications. Timepoint: Daily during treatment. Method of measurement: For blood and gastrointestinal complications, CBC test and clinical evaluation of the physician will be performed during treatment. Mashhad University of Medical Sciences Approved 2021-12-05 Ethics committee of Mashhad University of Medical Science Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)