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IRCT20221101056373N1 IRCT 2022-11-12 Sanandaj University of Medical Sciences Effect of Sublingual Atropine on Sialorrhea Induced by Clozapine Effect of Sublingual Atropine on Sialorrhea Induced by Clozapine in Patients with Schizophrenia 2022-12-22 anticipated 62 Complete https://irct.ir/trial/66659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 ( intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group), Blinding description: To blind the study, patients and their families do not know which of the intervention or control groups they are in. Also, the medicine and placebo are prepared in similar containers and in the same quantity, appearance and taste, and after coding by a psychiatric assistant, who does not know about the grouping, the drugs are prescribed. The final evaluation and summarization of the patients' findings will also be done by a psychiatric assistant who is not part of the group of study patients. 3 Clozapin induced sialorrhea. Intervention 1: Intervention group: After washing and cleaning the mouth, for 4 weeks and every night 1% hour before sleeping, two drops of atropine sulfate will be administered under the tongue. Intervention 2: Control group: After washing and cleaning the mouth, for 4 weeks and every night 1 hour before sleeping, two drops of placebo will be administered under the tongue. 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 Narges Shams alizadeh
Qods hospital, Entezam Blvd. pasdaran blvd
Sanandaj Iran (Islamic Republic of) 6617713141 +98 87 3366 0026 n.shamsalizadeh@muk.ac.ir Sanandaj University of Medical Sciences scientific Narges Shams alizadeh
Qods hospital, Entezam Blvd. pasdaran blvd
Sanandaj Iran (Islamic Republic of) 6617713141 +98 87 3366 0026 n.shamsalizadeh@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Diagnosed schizophrenia Current use of Clozapine for treatment Presence of drooling 18 years 60 years Both Pregnancy and breastfeeding Cardiovascular problems (arrhythmia, blood pressure, etc.) History of taking other anticholinergics Treatment - Drugs Placebo Intervention group: After washing and cleaning the mouth, for 4 weeks and every night 1% hour before sleeping, two drops of atropine sulfate will be administered under the tongue. Control group: After washing and cleaning the mouth, for 4 weeks and every night 1 hour before sleeping, two drops of placebo will be administered under the tongue. Sialorrhea. Timepoint: For 4 weeks and every night 1 hour before sleep. Method of measurement: Visual analogue scale and Drooling Rating Scale. Sanandaj University of Medical Sciences Approved 2022-09-21 Research Ethics Committees of Kurdistan University of Medical Sciences Pasdaran Blvd Sanandaj Kurdistan Iran (Islamic Republic of)