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IRCT20190602043790N2 IRCT 2020-06-27 Khoram-Abad University of Medical Sciences Comparison of Methylphenidate with the Combanition of Methylphenidate with Crocus sativus ( saffron) in the treatment of ADHD Comparison of Methylphenidate with the Combanition of Methylphenidate (MPH) and Crocus sativus (Saffron) in the treatment of children and adolescents with Attention-Deficit Hyperactivity Disorder (ADHD): a Randomized, Double Blind Clinical Trial 2020-06-21 anticipated 90 Complete https://irct.ir/trial/39997 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: Methylphenidate or a combination of Methylphenidate and Saffron. Even numbers are considered for the Methylphenidate group and odd numbers are for the Methylphenidate and Saffron group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients, Blinding description: Treatment allocation was concealed from the psychiatrist and the data analyser who rated patients by using successively numbered, opaque, and sealed envelopes. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to. 3 Attention-Deficit Hyperactivity Disorder. Intervention 1: Intervention group 1:The first group was treated with (MPH): The first group for 8 weeks uses10 -30 mg/d of Methylphenidate tablet (Created by Poorsina Pharmaceutical Company) depended on their weights daily . Intervention 2: intervention group 2: The second group received 10 -30 mg/d of Methylphenidate tablet with Saffron capsules (Created by Knowledge-based company "Pouyesh darooye Sina") for 8 weeks at a dose of 20–30 mg/d depending on their weight daily. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to main outcome or like that , can be share. When: Start of access, 6 months after publishing the results To whom: Only people working in academic institutions could apply. Conditions: People who are conducting clinical trials in this field could apply. Where to obtain: By referring to the electronic address: s.hasanvandi@alzahra.ac.ir How to obtain: The applicant can receive information by registering the exact personal details. Comments:
public Saba Hasanvandi
Lorestan University of Medical Sciences, Kilometer 5 Road of Tehran-Khorram Abad, Khorram Abad, Lorestan, Iran.
khorram Abad Iran (Islamic Republic of) 6813833946 +98 66 3324 2643 s.hasanvandi@alzahra.ac.ir Khoram-Abad University of Medical Sciences scientific Saba Hasanvandi
Kilometer 5 Road of Tehran-Khorram Abad, Lorestan University of Medical Sciences, Khorram Abad, Lorestan, Iran.
khorram Abad Iran (Islamic Republic of) 6813833946 +98 66 3330 0661 s.hasanvandi@alzahra.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM) Lack of mental retardation No use of Methylphenidate and Crocus sativus (saffron) before the study 6 years 16 years Both Parent's dissatisfaction to participate in study Psychiatric comorbidities (except for oppositional defiant disorder) Drug allergy F90.9 Attention-deficit hyperactivity disorder, unspecified type Treatment - Drugs Treatment - Drugs Intervention group 1:The first group was treated with (MPH): The first group for 8 weeks uses10 -30 mg/d of Methylphenidate tablet (Created by Poorsina Pharmaceutical Company) depended on their weights daily . intervention group 2: The second group received 10 -30 mg/d of Methylphenidate tablet with Saffron capsules (Created by Knowledge-based company "Pouyesh darooye Sina") for 8 weeks at a dose of 20–30 mg/d depending on their weight daily. Hyperactivity symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV). Attention-Deficit symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV). Impulsivity. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV). Khoram-Abad University of Medical Sciences Approved 2019-12-18 Ethics Committee of Lorestan University of Medical Sciences Kilometer 5 Road of Tehran-Khorram Abad, Lorestan University of Medical Sciences, Khorram Abad Khorram Abad Lorestan Iran (Islamic Republic of)