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IRCT20220406054433N1 IRCT 2022-04-23 Iran University of Medical Sciences Effect of common figs and almonds syrup, sweet almond syrup and methylphenidate in the treatment of attention deficit / hyperactivity disorder Comparison of the effectiveness of Persian Medicine products, common figs and almonds syrup, sweet almond syrup and methylphenidate in the treatment of attention deficit / hyperactivity disorder: A randomized double-blind clinical trial 2022-04-21 anticipated 120 Complete https://irct.ir/trial/62774 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done by randomized blocks using online sealed envelope software and 6 blocks of equal size, and patients will be randomly divided into one of three groups. Groups are identified and coded as A, B, C, and the prescriber and the recipient are unaware of this. Only the coordinator knows who in which group and which group received which treatment, Blinding description: The method of blinding the study will be that the drugs and placebo studied, including Ritalin tablets, sweet almond syrup, almond and fig syrup and ineffective syrup are packed in similar containers. The drug is given to the patient based on randomized sequences. And so the examiner and the patient are blind. 3 Attention-deficit hyperactivity disorder. Intervention 1: Control group: The first group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And a simple ineffective syrup as a placebo with the dose of 5 cc, three times a day. The simple syrup is made in the Pharmacy Department of the School of Traditional Medicine, Iran University of Medical Sciences according to British Pharmacopoeia. The duration of use is 12 weeks. Intervention 2: Intervention group: The second group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And sweet almond syrup at a dose of 5CC three times a day for 12 weeks. Sweet Almond Syrup is a syrup made in the Department of Pharmacy of the School of Persian Medicine, Tehran University of Medical Sciences, which is made of sweet almonds and raisins. This drug is currently available in the pharmaceutical market of Schools of Persian Medicine. Intervention 3: Intervention group: The third group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And Almond and fig syrup made by NIAK company with registration number 8953162594580741 in the Food and Drug Administration of the Islamic Republic of Iran. This drug is currently available in the pharmaceutical market of Schools of Persian Medicine. Yes - There is a plan to make this available What will be shared: Comparison of quantitative changes before and after the intervention is examined When: 1 year after the article was published To whom: Not planned Conditions: Not planned Where to obtain: Not planned How to obtain: Not planned Comments:
public Alireza Mahjoub
Behesht street, School of traditional medicine
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 ali_r_mahjoub@yahoo.com Iran University of Medical Sciences scientific Hoorieh Mohammadi Kenari
Behesht streer, School of traditional medicine
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5558 0388 mohammadikenari.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Children 6 to 14 years old suspected to ADHD Obtain informed consent from the child's parent or guardian Diagnosis of ADHD by a psychiatrist New diagnosis of the disorder and not taking another drug 6 years 14 years Both Mental retardation IQ <70 Simultaneous use of other methods of alternative and complementary medicine Having medical conditions including cardiovascular disease, gastrointestinal diseases, epilepsy Having other mental disorders including schizophrenia Existence of an organic brain problem Malnutrition and obvious growth disorders Recent treatment with antipsychotic drugs Drug dependence or abuse in the last 6 months History of allergies to sweet almonds and its products History of allergies to figs and its products Simultaneous consumption of other products containing almonds (nuts, almond sweets) and figs The need for behavioral therapy F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Placebo Treatment - Drugs Treatment - Drugs Control group: The first group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And a simple ineffective syrup as a placebo with the dose of 5 cc, three times a day. The simple syrup is made in the Pharmacy Department of the School of Traditional Medicine, Iran University of Medical Sciences according to British Pharmacopoeia. The duration of use is 12 weeks Intervention group: The second group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And sweet almond syrup at a dose of 5CC three times a day for 12 weeks. Sweet Almond Syrup is a syrup made in the Department of Pharmacy of the School of Persian Medicine, Tehran University of Medical Sciences, which is made of sweet almonds and raisins. This drug is currently available in the pharmaceutical market of Schools of Persian Medicine. Intervention group: The third group, they will receive the standard drug methylphenidate (Ritalin) with the dose of 1 mg / kg / day, In the first week (1.2 in the morning, 1.2 in the afternoon) and from the second week onwards (1 in the morning and 1 at noon) and if the patient weighs more than 30 kg, from the second week 3 tablets daily (1 Morning, 1 at noon and 1 at 4 pm). And Almond and fig syrup made by NIAK company with registration number 8953162594580741 in the Food and Drug Administration of the Islamic Republic of Iran. This drug is currently available in the pharmaceutical market of Schools of Persian Medicine. Severity of attention deficit / hyperactivity disorder based on the questionnaire score. Timepoint: At the beginning of the study (before the intervention), 4, 8 and 12 weeks after starting the drug. Method of measurement: Teacher and Parent ADHD rating scale. Evaluation of drug side effects. Timepoint: Once every 2 weeks after starting treatment. Method of measurement: Checklist of drug side effects and possible side effects based on CTCAE criteria (Common Terminology Criteria for Adverse Events v4.03, 2010). BMI, and clinical examination results. Timepoint: 4, 8 and 12 weeks after the start of the intervention. Method of measurement: questionnaire. Iran University of Medical Sciences Approved 2022-03-16 Research Ethics Committees of Iran University of Medical Sciences 5th floor, Headquarters Building, Iran University of Medical Sciences, Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)