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IRCT20200203046352N1 IRCT 2022-06-19 Shahid Beheshti University of Medical Sciences Impact of Risperidone in the treatment of fecal incontinence among children Comparison of the effect of Risperidone and placebo in the treatment of fecal incontinence in children 4 -18 years of age suffering from functional constipation and fecal incontinence, with and without neuropsychiatric disorders 2020-01-01 anticipated 140 Complete https://irct.ir/trial/45544 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering that BMI Z-score and psychological disorder can have a great impact on the results of the study, to ensure the uniform distribution of these variables in the groups, random allocation by Stratified Randomization and using the Permuted block randomization method with quadruple and binary blocks were used. Based on the sample size of 136 subjects, the quadruple block or double block were produced using the online site (www.sealedenvelope.com). Due to the double-blindness of the study, before starting the study, sets of packages containing Risperidone were prepared by someone other than the researcher, and the placebo was similar in appearance to Risperidone syrup. Indeed, researchers in the evaluation phase, from the allocation of participants in each of the groups (intervention and control group) until the end of the intervention, were not know the groups whereby the patients were randomized. In order to apply concealment in the randomization process, unique codes were used on the medicine boxes, and the desired code is also generated by the software. With this method of concealment, none of the participants and researchers know which of the two groups received the Risperidone or placebo. These codes were inserted on the packages by the company receiving the supplements and placebos. Upon each person entering the study, based on the sequence generated, the drug package in which the code is recorded was assigned to the parents. Also, the random sequence generated during the study was unpredictable, Blinding description: Medicine and placebo look exactly the same(shape, size, colour, smell). None of the participants are informed of receiving a placebo. Other than the manufacturer, nobody can differentiate medicine from a placebo. 3 Functional constipation, Fecal incontinence, NDD. Intervention 1: Intervention group: 34 patients with functional constipation and fecal incontinence who receive a daily dose of 0.25-0.5 mg (every 12 hours) of risperidone syrup for 12 weeks. Intervention 2: Control group: 34 patients with functional constipation and fecal incontinence who receive a daily dose of 0.25-0.5 mg (every 12 hours) of placebo. Yes - There is a plan to make this available What will be shared: We would like to share every document that will be resulted in this research by considering our patients personal information that are secret. Demographic data,signs and symptoms anf effect of our treatment When: After finalizing the research and evaluation the results and for unlimited time To whom: Gastroenterologist (adults and pediatrics) pediatricians, pediatric and general surgeons Conditions: By considering patients information as secret file Where to obtain: Pediatric gastroenterology,hepatology and nutrition research center ,Shahid Beheshti University of Medical Sciences,Tehran,Iran How to obtain: By formal e-mail Comments: none
public Dr. Ghazaal Zaahed
Mofid Chidren's Hospital, Shariati street, Tehran
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 ghazal.zahed@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Ghazaal Zaahed
Mofid Chidren's Hospital, Shariati street, Tehran
Tehran Iran (Islamic Republic of) 1546815524 +98 21 2222 7021 ghazal.zahed@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Functional constipation Fecal incontinence Age between 4 and 18 neuropsychiatric disorders in half of participants Absence of neuropsychiatric disorders in half of participants 4 years 18 years Both Anatomical and hormonal causes of constipation Presence of other GI disorders Treatment - Drugs Placebo Intervention group: 34 patients with functional constipation and fecal incontinence who receive a daily dose of 0.25-0.5 mg (every 12 hours) of risperidone syrup for 12 weeks. Control group: 34 patients with functional constipation and fecal incontinence who receive a daily dose of 0.25-0.5 mg (every 12 hours) of placebo Fecal incontinence. Timepoint: every month for 6 months. Method of measurement: interview with parents. Shahid Beheshti University of Medical Sciences Approved 2020-01-04 Pajoohan Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Koodakyaar dead end alley, Daaneshjoo Blvd, Chamraan highway Tehran Tehran Iran (Islamic Republic of)