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IRCT20211223053493N1 IRCT 2022-04-27 Arak University of Medical Sciences Comparison of the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2-6 years Comparison of the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2-6 years referred to the pediatric clinic of Amirkabir Hospital 2022-04-04 anticipated 150 Complete https://irct.ir/trial/61096 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Children 2 to 6 years old referred to the clinic who have been diagnosed with chronic constipation based on the ROME4 diagnostic criteria will be divided into three equal groups (pidrolax, lactulose, paraffin) using random allocation. This study will be randomized. In order to perform random allocation, random blocking method with 6 blocks such as AABBCC, ABBACC, BBAACC, AACCBB, BBCCAA, ACBCAB, etc. will be used, which will have numbers from 1 onwards, respectively. Then, by randomly selecting numbers from 1 to n , (n = number of possible cases of six blocks) , random sequences of three types of drugs will be identified for the study samples. Drug A means pidrolax, drug B is lactulose and drug C is paraffin, Blinding description: This is a single-blind clinical trial study in which only the data analyzer is blinded and the data is provided to the data evaluator in groups A, B, and C. The patient, researcher, and clinical caregiver are aware and not blinded. 3 Chronic functional constipation. Intervention 1: Intervention group: Intervention group 1: In Pidrolax group, the child is given 0.7 g / kg body weight (Sepidaj Pharmaceutical Company, Iran) orally in the morning fasting. Intervention 2: Intervention group: The second intervention group: in the lactulose group 1-2 cc / kg / day (Exir Pharmaceutical Company, Iran) will be given. Intervention 3: Intervention group: Third intervention group: In the paraffin group, oral paraffin (Mahdaro Pharmaceutical Company, Iran) will be given in the amount of 0.5 cc per kg every 12 hours. 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 Seyed Mojtaba Hashemi
Amirkabir Hospital, Parastar Square, Shahid Shiroodi St., Arak
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 mojtaba53hashemi@yahoo.com Arak University of Medical Sciences scientific Nooshin Sadjadei
Amirkabir Hospital, Parastar Square, Shahid Shiroodi St., Arak
Arak Iran (Islamic Republic of) 3819693181 +98 86 3313 4715 nooshin1sadjadei@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All children with chronic constipation for at least 6 months aged 2-6 years referred to the pediatric clinic of Amirkabir Hospital Parental consent Do not have any disease other than constipation Absence of any psychiatric disorders in the child or parents No maintenance in welfare or other places than family Not to receive constipation treatment for 2 weeks before inclusion in the study Not being a single parent Absence of IBS according to ROME IV criteria Absence of mental retardation or metabolic disease (such as hypothyroidism), Hirschsprung or spinal anomalies or anorectal pathology Absence of gastrointestinal surgery Not to receive medical treatment affecting GI motility such as cisapride, motilium, erythromycin, loperamide 2 years 6 years Both Lack of cooperation of parent or child Incidence of drug side effects and severe diarrhea Allergy to drugs K59.09 Other constipation Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group 1: In Pidrolax group, the child is given 0.7 g / kg body weight (Sepidaj Pharmaceutical Company, Iran) orally in the morning fasting. Intervention group: The second intervention group: in the lactulose group 1-2 cc / kg / day (Exir Pharmaceutical Company, Iran) will be given. Intervention group: Third intervention group: In the paraffin group, oral paraffin (Mahdaro Pharmaceutical Company, Iran) will be given in the amount of 0.5 cc per kg every 12 hours. Primary consequence : Number of defecation per week. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Secondary consequence : Stool consistency. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Secondary consequence : Number of abdominal pains per week. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Secondary consequence : Number of painful bowel movements per week. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Secondary consequence : Anorexia. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Secondary consequence : Nausea. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire. Arak University of Medical Sciences Approved 2021-07-18 Research Ethics committee of Arak University of Medical Sciences Alam al-Huda Street, Shahid Shiroodi Street, Arak Arak Markazi Iran (Islamic Republic of)