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IRCT20211222053481N1 IRCT 2022-02-17 Tabriz University of Medical Sciences Investigating The effect of melatonin on serum changes of Adropin in patients with diabetic retinopathy Investigating The effect of melatonin on serum changes of Adropin in patients with diabetic retinopathy 2022-02-20 anticipated 44 Complete https://irct.ir/trial/61932 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to create balance in the number of samples assigned to each of the studied groups, the blocking method is used. This method is based on simple randomization. In this method, we first determine a total sample volume, then randomly assign a set of them to group A and assign the remainder to group B. For this purpose, Random Allocation Software will be used under Windows (Version 1.0). This method is based on determining the total sample size (44 people) and the number of groups (n = 2) and then randomly a set of them (22 people) to group A or intervention and the rest (22 people) to group B or Controls are assigned and then one of them is randomly selected without replacement, Blinding description: In this study, two groups of patients, a total of 44 patients with diabetic retinopathy aged 65 to 75 years referred to a charity hospital or eye treatment centers are selected and studied. 22 patients from the group of patients are randomly selected as the negative control group without melatonin and receiving only routine treatment (-Melatonin) and the remaining 22 will be selected as the treatment group (+ Melatonin) with melatonin in addition to routine treatment. Sampling is done before and after both groups, before the start of melatonin consumption and after the end of the course, and the samples are sent to the laboratory as a number (code) to measure the registered parameters and the answers are obtained for each serum number. N/A Diabetic Retinopathy. Intervention 1: Intervention group: Diabetic patients with retinopathy. In this study, a total of 44 patients with diabetic retinopathy aged 65 to 75 years who are referred to Nikokary hospital is selected. Twenty-two patients will be randomly selected as the intervention group (+ Melatonin). The intervention group will receive 3 mg of oral melatonin capsule (Norm Life Melatonin Vanatonin) for 60 days in addition to their normal and routine treatment. Before the start of melatonin administration and at the end of the study course, on day 60, blood samples will be taken from both intervention and control patient groups. Finally, the collected serums will be biochemically analyzed and the results will be statistically analyzed along with the results obtained from clinical examinations, and finally, the results will be extracted and reported. Intervention 2: Control group: 22 patients will be randomly assigned to the negative control group without melatonin and only their usual treatment. Blood samples will be taken from both study groups before the start of the study and after the end of the course, ie on the 60th day. Finally, the collected serums will be biochemically analyzed and the results will be statistically analyzed along with the results obtained from clinical examinations, and finally, the results will be extracted and reported. 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 Alireza Javadzadeh
Tabriz university of medical sciences, university Ave,
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3442 6078 javadzadeha@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Alireza Javadzadeh
Tabriz Univesity of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1336 4666 javadzadeha@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic retinopathy Patients without a history of melatonin use Age range 65 to 75 years 65 years 75 years Both History of melatonin use History of using antioxidant compounds such as doxium Has not consumed the essential elements with antioxidant properties Antioxidant vitamins such as vitamins C and E.Not consumed E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy Prevention N/A Intervention group: Diabetic patients with retinopathy. In this study, a total of 44 patients with diabetic retinopathy aged 65 to 75 years who are referred to Nikokary hospital is selected. Twenty-two patients will be randomly selected as the intervention group (+ Melatonin). The intervention group will receive 3 mg of oral melatonin capsule (Norm Life Melatonin Vanatonin) for 60 days in addition to their normal and routine treatment. Before the start of melatonin administration and at the end of the study course, on day 60, blood samples will be taken from both intervention and control patient groups. Finally, the collected serums will be biochemically analyzed and the results will be statistically analyzed along with the results obtained from clinical examinations, and finally, the results will be extracted and reported. Control group: 22 patients will be randomly assigned to the negative control group without melatonin and only their usual treatment. Blood samples will be taken from both study groups before the start of the study and after the end of the course, ie on the 60th day. Finally, the collected serums will be biochemically analyzed and the results will be statistically analyzed along with the results obtained from clinical examinations, and finally, the results will be extracted and reported. Serum changes of Adropin. Timepoint: Measurement of serum Adropin levels before intervention and 60 days after melatonin administration. Method of measurement: ELISA Method. Tabriz University of Medical Sciences Approved 2022-02-02 Ethics committee of Tabriz University of Medical Sciences Daneshghah Ave. Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)