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IRCT20190410043224N1 IRCT 2020-02-20 Esfahan University of Medical Sciences Comparison between the Golghand majun and Polyethylene glycol in the pediatric constipation Comparative evaluation between the Golghand majun (Rosa damascena) and Polyethylene glycol (4000) in the pediatric functional constipation in chidren 2 to 15 years old referred to Emam Hossein hospital in 2019-2020 2020-02-20 anticipated 60 Complete https://irct.ir/trial/44560 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into intervention and control groups using simple random number table (individual and simple randomization). The intervention group was allocated to the treatment of the Golghand majun and the control group was allocated to the proven treatment of constipation (administration of Polyethylene glycol powder). 3 Functional constipation. Intervention 1: Golghand majun (Barij Pharmaceutical Company) 500 mg / kg divided in three times daily, orally half an hour before meals for eight 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 Saeedeh Ghaedi
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Ghaedi_saeedeh@yahoo.com Esfahan University of Medical Sciences scientific Peiman Nasri
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
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 ROMAN criteria 4 Stool elimination twice a week or less History of stool retention Stiff or painful intestinal function History of large stool diameter History of large stool mass in rectum 2 years 15 years Both Patients with causes of organic constipation such as celiac disease, pseudo-obstruction, hypothyroidism, spinabifida, anorectal malformation, hirschsprung's disease Patients with chronic illness who need special care such as: stone kidney, sickle cell anemia, cereberal palsy, hepatitis, hematologic diseases, gastrointestinal bleeding, relapse fever or fever without locolized sign Pregnanccy History of surgery involvig the gastrointestinal tract exept for appendectomy History of allergies or drug allergies Diagnosis of autism, major psychosis disorder such as bipolar disorder, schizophrenia, children who have experienced physical abuse and sexual abuse Use of medication such as Metoclopyramide, Erythromycin, Butanol, Amoxiclav, Azithromycin, Domperidone, Amitriptyline, Hyoscyamine, Clonidine, Baclofen, Dicyclomine, Scopolamine Weight loss over five percent in the past three monthes Use of drugs that have an unknown delay in the gastrointestinal tract K59.09 Other constipation Treatment - Drugs Treatment - Drugs Golghand majun (Barij Pharmaceutical Company) 500 mg / kg divided in three times daily, orally half an hour before meals for eight 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 2019-09-15 Isfahan University of Medical Sciences Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)