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IRCT20200404046938N1 IRCT 2022-02-19 Tehran University of Medical Sciences Evaluation of the effectiveness of oxytocin by placebo nasal spray on symptoms and treatment of adults with autism Comparison of the effectiveness of oxytocin nasal spray with placebo on symptoms and treatment of adults with autism: a randomized clinical trial 2022-03-21 anticipated 40 Complete https://irct.ir/trial/56558 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was performed. It was an individual randomization unit. Forty adult patients with autism spectrum disorder are numbered from 1 to 40 in the Excel file. Then in Random Allocation software, the number of patients was 40. The number of groups was set at 2. Group 1 case name and group 2 placebo name were determined. Then the software determined which number is in the case group and which number is in the placebo group. The numbers were matched with an Excel file containing the patients' names, thus identifying the case and control groups, Blinding description: Patients and their companions and the prescribing physician will be unaware of which is the main drug and which is the placebo.There will be only codes on the bottles that will be registered with the name of the person when prescribing to the patient. 3 Autistic Disorder. Intervention 1: Intervention group: Oxytocin nasal spray, including oxytocin peptide, 25 ml bottle, 2 times a day, two puffs in each nostril, including 48 international units of oxytocin daily, for 8 weeks, Pharma Globe (Pharma Grid) UK. Intervention 2: Control group: normal saline nasal spray, 25 ml, twice a day, two puffs per nose, for 8 weeks, Jaber Ibn Hayyan Co. 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 Saba Faraji Niri
No 151,razi tower,saboori ave,kashanak ave,niavaran square,tehran
Tehran Iran (Islamic Republic of) 1978976181 +98 21 2282 9356 S_farajin@razi.tums.ac.ir Tehran University of Medical Sciences scientific Saba Faraji Niri
No 151,razi tower,saboori ave,kashanak ave,niavaran square,tehran
Tehran Iran (Islamic Republic of) 1978976181 +98 21 2282 9356 S_farajin@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 16 years and zero months to 55 years and 11 months Confirmation of diagnosis by a psychiatrist based on dsm5 Complete physical examination and normal laboratory tests Ability to understand and speak Persian fluently Ability to read and understand the consent form in full and if it is not possible for the legal guardian to read and sign the form Clinical global impression-severity CGI-S score above 4 in screening Intelligence score in Stanford test - above 75 16 years 56 years Both Patients with nasal septal deformity and previous epithelial injuries and a history of nasal surgeries with a risk of nasal epithelium damage and people with a history of inhaled substance use Patients with nasal congestion due to colds Patients in the acute phase of psychiatric illness or with thoughts of death and suicide Having a history of neurological diseases, seizures and head injuries People with a history of neurological or metabolic disease that affects their sensory and motor function, etc. Receive stimulant medications History of uncontrolled cardiovascular, renal and hepatic diseases Pregnant women or young women who do not take oral contraceptives People whose type and dose of psychiatric medication have changed in the last 4 weeks People with a history of chronic oxytocin treatment History of allergy to oxytocin and syntocinin and all its compounds asthma F84.0 Autistic disorder Treatment - Drugs Placebo Intervention group: Oxytocin nasal spray, including oxytocin peptide, 25 ml bottle, 2 times a day, two puffs in each nostril, including 48 international units of oxytocin daily, for 8 weeks, Pharma Globe (Pharma Grid) UK. Control group: normal saline nasal spray, 25 ml, twice a day, two puffs per nose, for 8 weeks, Jaber Ibn Hayyan Co. Improving the social symptoms of adults with autism. Timepoint: Start of study, 4 weeks later, 8 weeks later. Method of measurement: Social responsiveness scale -social motivation subscale (SRS). Tehran University of Medical Sciences Approved 2021-04-27 Ethics committee of Tehran University of Medical Sciences Tehran university of medical sciences,school of medicine,poursina street,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)