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IRCT20101130005280N63 IRCT 2023-12-18 Mashhad University of Medical Sciences Comparing the effect of saffron extract with methylphenidate in hyperactivity disorder Comparing the effect of saffron extract with methylphenidate on impulsivity and attention deficit scores in 6-12-year-old children with attention deficit hyperactivity disorder 2024-01-02 anticipated 60 Complete https://irct.ir/trial/73974 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 patients are randomized simply using a table of random numbers. To use the table of random numbers, first, the framework of the statistical community is determined (60 people); respectively, we give them a code or serial number. Codes and numbers should be equal to that assigned to the members of society; for example, in our research, we give two-digit codes to people, such as 01, 02, 03, ..., 11, 12,... To select sample people from the table, we randomly start from a point in the row or column direction. We can choose the point by closing our eyes and placing a finger or pen tip on the table. Moving in the row or column direction does not differ and is optional. But according to the type of code digits (one digit, two digits, three digits, etc.), we must choose the same number of digits in the direction of a row or column. After this, we control the route numbers. Whether we like it or not, we will come across two types of numbers, one smaller than the number of the studied community and the other larger than the number of the community. We should pay attention to and choose only the smaller numbers. The selected number is the code of an individual from the community chosen as a sample. This work should continue until the sample people can be selected as small as possible. After the sample volume is complete, the sampling work ends. The numbers will be placed in sealed envelopes, and when the participants enter, an envelope will be assigned to each of them, and they will be placed in one of the two intervention groups. 2-3 Attention deficit hyperactivity disorder (ADHD). Intervention 1: Intervention group: In addition to treatment with methylphenidate for 6 weeks, children under 30 kg will receive Etansaf capsules containing ten milligrams of dry saffron extract twice a day and children over 30 kg three times a day. Intervention 2: Control group: Patients in the control group will be treated with usual drugs (methylphenidate) twice a day. 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 En After finishing work, consult with colleagues and it will be published if all members
public Asieh Hosseinpour
Ibn Sina Psychiatric Hospital, Bu Ali Square, Mashhad
Mashhad Iran (Islamic Republic of) 99199-91766 +98 903 926 4520 seyedhosseinkhademi1401@gmail.com 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) 99199-91766 +98 71 12721 mohararif1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age range between 6-12 years Diagnosis of attention deficit hyperactivity disorder based on DSM-5 criteria Informed parental consent IQ in the normal range (based on interviews and previous records) Not having a clear organic disease (based on the history obtained from the patient's family) Not suffering from other psychiatric disorders (based on a structured interview conducted by a specialist in child and adolescent psychiatry) 6 years 12 years Both Suffering from any type of systemic or psychiatric disease or other psychiatric disorders that require medication Impossibility of examining the patient carefully due to unavailability Substance dependence F90.9 Attention-deficit hyperactivity disorder, unspecified type Placebo Diagnosis Intervention group: In addition to treatment with methylphenidate for 6 weeks, children under 30 kg will receive Etansaf capsules containing ten milligrams of dry saffron extract twice a day and children over 30 kg three times a day. Control group: Patients in the control group will be treated with usual drugs (methylphenidate) twice a day Impulsivity score. Timepoint: At the beginning of the study and 6 weeks later. Method of measurement: by Connors parent questionnaire to evaluate attention deficit hyperactivity disorder. Attention deficit score. Timepoint: At the beginning of the study and 6 weeks later. Method of measurement: by Connors parent questionnaire to evaluate attention deficit hyperactivity disorder. Mashhad University of Medical Sciences Approved 2023-11-20 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)