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IRCT20101130005280N38 IRCT 2021-05-18 Mashhad University of Medical Sciences Effect of sour cherry juice concentrate and Melatonin tablet on improving sleep disorders in children with ADHD Comparative investigation of the effect of sour cherry juice (tart cherry) concentrate and Melatonin tablet on improving sleep disorders in children with Attention Deficit Hyperactivity Disorder 2021-07-05 anticipated 70 Complete https://irct.ir/trial/56263 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization using "random allocation" software will be conducted. In this type of randomization, blocking is usually used to create a balance in the number of samples assigned to each of the studied groups. This study has 17 blocks of 4 and one block of 2. Half of each block belongs to the patients of the control group and the other half belongs to the intervention group. 3 Attention-deficit hyperactivity disorders. Intervention 1: Control group: In this group, patients are given Melatonin tablets (maximum dose of 3 mg) every night for 8 weeks. Intervention 2: Intervention group: Patients in this group receive cherry concentrate containing melatonin every night for 8 weeks. The amount of sour cherry juice concentrate consumption in the intervention group is adjusted so that the amount of melatonin intake is exactly the same as the control group (standardization based on active ingredient). Sour cherry juice will be purchased from Khoosheh Sorkh Shargh Company which is one of the reputable companies in the field of concentrate production. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Dr Fatemeh Moharari
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2721 mohararif1@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Fatemeh Moharari
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2721 mohararif1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age range between 6 and 12 years Attention Deficit Hyperactivity Disorder based on DSM-5 criteria Sleep disorder IQ is within normal range No obvious organic disease 6 years 12 years Both Having any other systemic or psychiatric illness that requires medication Taking medication for treatment of insomnia Taking other psychedelic drugs that affect sleep Addiction to drugs F90 Attention-deficit hyperactivity disorders Treatment - Drugs Treatment - Drugs Control group: In this group, patients are given Melatonin tablets (maximum dose of 3 mg) every night for 8 weeks. Intervention group: Patients in this group receive cherry concentrate containing melatonin every night for 8 weeks. The amount of sour cherry juice concentrate consumption in the intervention group is adjusted so that the amount of melatonin intake is exactly the same as the control group (standardization based on active ingredient). Sour cherry juice will be purchased from Khoosheh Sorkh Shargh Company which is one of the reputable companies in the field of concentrate production. Quality of sleep in patients. Timepoint: At the beginning of the study and 8 weeks after taking medication. Method of measurement: Children's Sleep Habits Questionnaire (CSHQ). Sleep duration. Timepoint: At the beginning of the study and 8 weeks after taking medication. Method of measurement: Children's Sleep Habits Questionnaire (CSHQ). Rate of attention deficit. Timepoint: At the beginning of the study and 8 weeks after taking medication. Method of measurement: Conners' Parent Rating Scale. Rate of symptoms of hyperactivity. Timepoint: At the beginning of the study and 8 weeks after taking medication. Method of measurement: Conners' Parent Rating Scale. Mashhad University of Medical Sciences Approved 2019-12-04 Ethics Committee of Mashhad University of Medical Sciences Daneshgah street, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)