Evaluating the effectiveness of silymarin in preventing vancomycin-induced nephrotoxicity in hospitalized patients

Determining the effectiveness of silymaran in preventing vancomycin-induced nephrotoxicity in patients admitted to Namazi and Shahid Faqihi hospitals in Shiraz

The clinical trial has two control and treatment groups, double-blind, randomized by permutation block method.

A multicenter, randomized, double-blind, placebo-controlled clinical trial in two educational medical centers in Shiraz including Namazi Hospital and Shahid Faqihi Hospital Preparing the placebo as the same as Livergol tablets regarding size, color, and shape The unawareness of the nursing staff about groups The unawareness of the physician and assistant researcher about groups

Patients referred to teaching hospitals who have been diagnosed with an indication for the use of systemic (injectable) vancomycin for at least 7 days. The patients are hemodynamically stable, willing to participate in the study, receiving vancomycin injection for at least 7 days, absence of hypersensitivity reaction following silymarin consumption, no confirmed history of acute kidney injury, no confirmed history of chronic kidney disease, no vancomycin use in the past 14 days, no simultaneous use of drugs or compounds with antioxidant effect, no simultaneous use of drugs with prominent nephrotoxicity, and oral tolerance to drugs

The two treatment and control groups will be given vancomycin based on the treatment protocol. However, in the patients of the treatment group, silymarin tablets (Livergol) 140 mg three times a day will be given orally as long as vancomycin is prescribed.

Increase in serum creatinine level; Development of acute tubular necrosis (ATN); The change in oxidant and antioxidant markers in serum

Block randomization (quadruple blocks): All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB. We need 20 blocks to select 80 people. We randomly select these blocks from the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-B-A-A-B-B, respectively. Finally, group A receives placebo and group B receives silymarin.

The researcher does not know whether the drug he gives to the patient is a placebo or the original drug. On the other hand, the participant (patient) is also unaware of whether the drug given to him is a placebo or the original drug.