Investigating the effect of melatonin on glomerular filtration rate, proteinuria and appetite in adult patients with chronic renal failure: a double-blind randomized clinical trial study

Determining the effect of melatonin on glomerular filtration rate, proteinuria rate and appetite rate in adult patients with chronic renal failure

Clinical trial with control group, factorial, double-blind, randomized, phase 3 on 140 patients. For randomization, the table of random allocation of samples is used

patients aged 18 to 80 years with chronic renal failure and proteinuria referring to nephrology offices and subspecialty clinics in Yasouj city were randomly assigned into two intervention and placebo groups; after two months of taking 5 mg daily Melatonin drug is evaluated in terms of changes in glomerular filtration, proteinuria and appetite. The patient and the researcher are blinded to the study group

Study entry criteria: 1- Patients with chronic kidney disease 2- Patients with persistant proteinuria 3- Be able to cooperate and communicate 4- The patient is not on dialysis 5- Have signed the consent form to enter the study Criteria for not entering the study: 1- Suffering from a severe physical, neurological or psychiatric illness and not being able to continue to cooperate. 2- Drug sensitivity or allergic reaction to drugs 3- Patients taking immunosuppressive drugs 4- Patients with liver enzyme disorders 5- Patients with seizure disorders and taking anticonvulsant drugs

1- Melatonin group: In this group, 5 mg of melatonin is used daily for 2 months 2- Placebo group: In this group of patients, in addition to receiving their previous medications, for 2 months, they use a placebo in the form of capsules of the same shape and weight as the medicine of the intervention group

proteinuria; glomerular filtration; appetite

Sampling will first be available and then random allocation. The samples that meet the inclusion criteria are selected, then by block random allocation using the random allocation table, the samples will be divided between the two melatonin groups and the placebo group.

In this study, after preparing the complete list of participants in the study, people are randomly placed in two groups A and B (melatonin and placebo) based on computer software and simple random assignment method. Then each drug group corresponds to the group which are completely the same shape, color and weight, and the researcher and the participant in the study are not aware of the type of drug, and it is given in advance by a third person who was outside the study, and at the end of the study, the variables are The researcher is measured.