Investigating the effect of oral melatonin on urinary tract infection in children and adolescents

Determining the effect of melatonin on urinary tract infection in children and adolescent

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Randomized permutation block method was used for randomization.

100 patients with urinary tract infection and simultaneous sleep disorder referring to Amirkabir Arak Hospital were divided into two intervention groups (receiving 5 mg melatonin tablets daily for 10 days along with antibiotics) and control (antibiotics with placebo) in the form of block randomization. will be After explaining the purpose and steps of the study to the parents of the patients, a checklist is completed for each person, in which the child reports abdominal pain, burning and frequency of urination to the parents on the days under study, and their improvement is checked during the study.

Inclusion criteria: Children aged 4-18 with urinary tract infections and sleep disorders at the same time, consent to participate in the study; Inclusion criteria: The presence of underlying kidney disease

In the control group, patients receive antibiotics and placebo for 10 days as a standard treatment for urinary infection. In the intervention group, in addition to antibiotics, patients will receive 5 mg melatonin tablets produced by Jalinous Iranian Pharmaceutical Company at a dose of 5 mg once a day for 10 days.

Fever above 38 degrees Celsius, Dysuria, frequency and its number of occurrences, abdominal pain, urinary incontinence, and its number of occurrences

Block randomization is done by a statistician with blocks of 6 along with the randomization code through the site sealedenvelope.com

To conduct this double-blind study, before starting the investigation, the total number of capsules for both the intervention and control groups, which are identical in shape, color, and appearance and obtained from the same pharmaceutical company, will be coded as A and B by a person other than the researcher to ensure that the researcher remains unaware of which type of capsules each group receives. Additionally, the participants, who are randomly assigned to groups A and B without knowledge of whether they are in the supplement or placebo group, will receive the capsules for a duration of 10 days.