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IRCT20190410043224N3 IRCT 2020-06-21 Esfahan University of Medical Sciences Comparison between the laxa plus barij and Polyethylene glycol in the pediatric constipation Comparative evaluation between the laxa plus barij and Polyethylene glycol (4000) in the pediatric functional constipation in chidren 2 to 15 years old 2020-06-21 anticipated 60 Complete https://irct.ir/trial/48124 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are selected among the target community according to the entry and exit criteria by convenience non probability method ,then they are randomly allocated into intervention and control groups by Random allocation software developed by Dr.Mahmoud Saghaei. 3 Functional constipation. Intervention 1: Intervention group: Laxa plus barij 1cc/kg daily divided in 3 times ,in the children with body weight less than 30 kg and 10cc 3 times daily,in the children with body weight more than 30 kg orally half an hour before meals for 8 weeks. Intervention 2: Control group: Polyethylene glycol (4000) Powder (Sepidaj Pharmaceutical Company) 0.7 g / kg orally three times daily for eight weeks. 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 Shima Saeidi
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 shimasaeidi369@gmail.com Esfahan University of Medical Sciences scientific Peiman Nasri
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan City
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Peiman94157@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Functional constipation confirmed by ROME 4 criteria Defecation twice a week or less; History of stool retention; history of painful defecation; History of large stool diameter; History of large stool mass in rectum; 2 years 15 years Both Patients with stractural causes of constipation such as celiac disease; pseudo-obstruction; hypothyroidism; spina bifida, anorectal malformation; hirschsprung's disease; Patients with chronic illness who need special care such as: renal stone; sickle cell anemia; cerebral palsy; hepatitis; hematologic diseases; gastrointestinal bleeding; recurrent fever or fever without locolized sign; Pregnanccy; History of gastrointestinal tract surgery exept for appendectomy; History of allergy or Drug sensitivity; autism; major psychotic disorder such as bipolar disorder; schizophrenia; Children who had experienced physical abuse and sexual abuse; Use of medication such as Metoclopramide, Erythromycin, Bethanechol, CoAmoxiclav, Azithromycin, Domperidone, Amitriptyline, Hyoscyamine, Clonidine, Baclofen, Dicyclomine, Scopolamine; Weight loss more than five percent in the past three monthes; Using drugs that have an unknown effect on the gastrointestinal tract K59.09 Other constipation Treatment - Drugs Treatment - Drugs Intervention group: Laxa plus barij 1cc/kg daily divided in 3 times ,in the children with body weight less than 30 kg and 10cc 3 times daily,in the children with body weight more than 30 kg orally half an hour before meals for 8 weeks Control group: Polyethylene glycol (4000) Powder (Sepidaj Pharmaceutical Company) 0.7 g / kg orally three times daily for eight weeks Constipation improvement. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Clinical Examination; Questionnaire of Constipation Evaluation. Treatment side effects. Timepoint: During the study and 8 weeks after the intervention. Method of measurement: Clinical Examination; Questionnaire of Constipation Evaluation. Barij Medicinal Plant Research Center Approved 2020-04-27 Ethics committee of Esfahan University of Medical Sciences Imam Khomeini/ children hospital Imam hossein Esfahan Isfehan Iran (Islamic Republic of)