Evaluation of the effect of melatonin in reducing migraine attacks in comparison with standard treatment in patients treated in Shahid Sadoughi Hospital in Yazd, a double-blind randomized clinical trial

Determining the effect of melatonin on reducing the severity of migraine attacks in patients with migraine

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 is conducted on 80 patients. Patients are entered into two groups of 40 people, medicine or intervention based on permutation block method. The number of 10 blocks of 8 is considered. The first eligible person to enter the study is given the number one and so on until the last eligible person is given the number 80. In order to hide the random allocation, this list will be given to another person outside the study, and before assigning the type of treatment, they will be asked according to the number of the eligible person, and in this way, the people will enter the study.

Neurological diseases clinic of Shahid Sadoughi Yazd Hospital will cover all the above steps from the perspective of the patient and the attending physician. In this way, the first executor determines the sequence of assigning people according to the order in which the patients enter the study and puts the drugs in uniform envelopes for the patient's use and identifies them with A or B codes Then, according to the above description, she selects the appropriate medicines for each person and puts them in special envelopes and delivers them to the patients.

inclusion criteria: Age over 18 years/all patients with migraine referred to the neurology clinic of Shahid Sadoughi Hospital, Yazd. Exclusion criteria: lack of consent to participate in the study/pregnancy/breastfeeding

The control group received standard treatment with placebo and the sample group received standard treatment with melatonin 5 mg daily for three months.

Reducing the severity of migraine attacks

Patients are entered in two groups of 40 people, drug or intervention based on the permutation block method. The number of 16 blocks of 5 is considered. The generation of random codes will be generated using random allocation using the permutation block method with the help of Random allocation software version 1. The first eligible person to enter the study is given the number one, and so on until the last eligible person is given the number 80. By using the table generated by the random allocation software according to the number, the intervention people (A or B) will receive each of the letters A and B installed on containers of the same shape and assigned to one of the interventions.In order to hide the random allocation, this list will be given to another person outside the study, and before assigning the type of treatment, they will be asked according to the number of the eligible person, and in this way, the people will enter the study.

All the above steps will be hidden from the view of the patient, treating physician, and evaluators. In this way, the first executor determines the sequence of assigning people according to the order in which the patients enter the study and puts the drugs in uniform envelopes for the patient's use and identifies them with A or B codes. Then, according to the above description, he selects the appropriate medicines for each person and puts them in special envelopes and delivers them to the patients.

The data collected from the samples in line with the special objectives of the study

The access period starts 6 months after the results are published

Faculty members of Iran Universities of Medical Sciences, Faculty of Pharmacy

They are only allowed to perform new analyzes that improve the status of the results

By introducing yourself and your request via email to the corresponding author

After there is a logical reason