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IRCT20160530028182N11 IRCT 2023-10-10 Kurdistan University of Medical Sciences Evaluation of the efficacy of Zinc sulfate and fluoxetine in obsessive_compulsive Evaluation of the efficacy of zinc sulfate and fluoxetine in comparison with fluoxetine with placebo in children and adolescents with obsessive-compulsive disorder 2022-08-16 anticipated 42 Complete https://irct.ir/trial/65302 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Sampling is done by simple random sampling. Placement or allocation of patients in two groups will be done by simple random method and by software. Then the grouping of the patients is given to the referee specialist and based on the given codes, he puts the necessary drugs in sealed envelopes, which will be numbered on the envelopes, and based on the order of the patient's visits, the corresponding envelope will be given to the patient by the relevant pharmacy. The patient and the doctor do not know about the contents of the envelope. Medicines are placed in capsules in the form of crushed tablets, and the shape of the two medicines is the same, Blinding description: Placement or allocation of patients in two groups will be done by simple random method and by software. Then the grouping of the patients is given to the referee specialist and based on the given codes, he puts the necessary drugs in sealed envelopes, which will be numbered on the envelopes, and based on the order of the patient's visits, the corresponding envelope will be given to the patient by the relevant pharmacy. The patient and the doctor do not know about the contents of the envelope. Medicines are placed in capsules in the form of crushed tablets, and the shape of the two medicines is the same. 3 Obssesive_compulsive disorder. Intervention 1: "Intervention group:" for this group, patients fluoxetine capsules manufactured by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning) and the third week (Ravazneh, 20 mg) and then from The fourth week onwards based on the patient's tolerance (Ravazneh, 30 mg) plus zinc sulfate manufactured by Al-Hawi company for the first week (daily, 6.25 mg), for the second week (12.5 mg daily) and for the third week onwards Based on the patient's tolerance (25 mg daily in the morning) is given for 8 weeks. Intervention 2: Control group: For this group, patients were given a placebo in capsules similar to Alhawi zinc sulfate containing starch, plus fluoxetine capsules made by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning). and the third week (Ravazaneh, 20 mg) and then from the fourth week onward based on the patient's tolerance (Ravazaneh, 30 mg) is given. 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 further information.
public Soleiman Mohammadzadeh
Kurdistan University of Medical Sciences, Pasdaran Street
Sanandaj Iran (Islamic Republic of) 1344666177 +98 87 3323 2168 dr.mohammadzadeh86@muk.ac.ir Kurdistan University of Medical Sciences scientific Soleiman Mohammadzadeh
Behsat Hospital, Kurdistan University of Medical Sciences
Sanandaj Iran (Islamic Republic of) 1344666177 +98 87 3328 5914 dr.mohammadzadeh86@gmail.com Kurdistan University of Medical Sciences Iran (Islamic Republic of) Age 10-17 years Based on the diagnostic criteria of DSM-5, obsessive-compulsive disorder should be diagnosed in children by a specialist in child and adolescent psychiatry. 10 years 17 years Both Existence of accompanying psychiatric disorder except for anxiety disorders and oppositional defiant disorder- Mental retardation based on clinical suspicion History of allergy to zinc sulfate Wilson's disease according to medical statements and documents Liver disease based on medical statements and documents Spending drug treatments in the previous 2 months Suicidal thoughts F42 Obsessive-compulsive disorder Treatment - Drugs Placebo "Intervention group:" for this group, patients fluoxetine capsules manufactured by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning) and the third week (Ravazneh, 20 mg) and then from The fourth week onwards based on the patient's tolerance (Ravazneh, 30 mg) plus zinc sulfate manufactured by Al-Hawi company for the first week (daily, 6.25 mg), for the second week (12.5 mg daily) and for the third week onwards Based on the patient's tolerance (25 mg daily in the morning) is given for 8 weeks. Control group: For this group, patients were given a placebo in capsules similar to Alhawi zinc sulfate containing starch, plus fluoxetine capsules made by Obeid company for the first week (daily, 5 mg in the morning), the second week (daily, 10 mg in the morning). and the third week (Ravazaneh, 20 mg) and then from the fourth week onward based on the patient's tolerance (Ravazaneh, 30 mg) is given. Obsessive compulsive scor in Fua et al.'s 2010 Obsessive Compulsive Questionnaire, Children's Version, 21 items (OCI-CV). Timepoint: At the beginning of the study, 4 weeks later, at the end of 8 weeks. Method of measurement: Fowa et al.'s 2010 Children's Version 21-item Obsession Questionnaire (OCI-CV). Kurdistan University of Medical Sciences Approved 2022-07-26 Ethics Committee of Kurdistan University of Medical Sciences Qods hospital, Entezam Blvd, sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)