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IRCT201107026932N1 IRCT 2011-08-22 Shahed University - Faculty of Medical Sciences Efficacy of Cassia Fistula in constipation Determination the efficacy of Cassia Fistula in management of pediatric functional constipation 2011-06-22 anticipated 72 Complete https://irct.ir/trial/7390 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Constipation. Intervention 1: Intervention group: Aqueous extract of Cassia fistula’s fruit’s pulp (in form of syrup), 0.15 g/Kg/day, orally, divided in 2 or 3 separated dose, after meals, for 21 days. Intervention 2: Control group: Mineral oil, 1-4 teaspoons, orally, divided in 2 or 3 separated dose, after meals, for 21 days.
public Seyyed Ali Mozaffarpur
Group of
Tehran Iran (Islamic Republic of) +98 21 8899 6212 seyyedali1357@gmail.com scientific Dr. Mohsen Naseri
"Salamat" clinic- besides "Mostafa Khomeini" hospital- "Italia" Avenue- Tehran-
Tehran Iran (Islamic Republic of) 00982188996213-00982188967573 naseri@shahed.ac.ir Shahed University- Faculty of Medical Scienses-Group of Medical Scienses Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: children between 4 to 13 years old who have at least 2 or more of the followings: Less than 2 defecations in the toilet each week, More than 1 episode of fecal incontinence per week, History of retentive posturing or excessive volitional stool retention, History of painful or hard bowel movements, Presence of a large fecal mass in the rectum, History of large diameter stools that may obstruct the toilet, children with inclusion criteria are visited by pediatric gastroentrologist to provide complete functional constipation criteria. If the history and physical examination or question is not for functional constipation, ano-rectal manometry is performed Exclusion criteria: any symptom of organic constipation in the history or physical examination, any evidence of organic constipation in anorectal manometry, fecal impaction on physical examination that cannot be removed, presence of other chronic diseases that lead to long-term use of drugs, Long-term consumption of drugs that can cause constipation, intolerance of drinking cassia syrup (nausea and vomiting or severe abdominal pain or allergic symptoms), no compliance, the patient's unwillingness to continue treatment, Note: If any complication due to drugs (such as crampy abdominal pain, probable electrolyte disorder signs due to severe diarrhea (potassium imbalance), muscle weakness or palpitation, and facial and limbs edema, or other complications that are possibly related to drugs) happen, the treatment will be discontinued the adverse effect are recorded. 4 years 13 years Both K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: Aqueous extract of Cassia fistula’s fruit’s pulp (in form of syrup), 0.15 g/Kg/day, orally, divided in 2 or 3 separated dose, after meals, for 21 days Control group: Mineral oil, 1-4 teaspoons, orally, divided in 2 or 3 separated dose, after meals, for 21 days Number of defications per week. Timepoint: before intervention and 7, 14, 21 days after begining of the intervention. Method of measurement: questionairre. Intensity of stiffness of the stool in defication. Timepoint: before intervention and 7, 14, 21 days after begining of the intervention. Method of measurement: questionairre and VAS. Intensity of pain of defication. Timepoint: before intervention and 7, 14, 21 days after begining of the intervention. Method of measurement: questionairre and VAS. Frequency of fecal incontinence per week. Timepoint: before intervention and 7, 14, 21 days after begining of the intervention. Method of measurement: questionaire. Frequency of fecal soiling per week. Timepoint: before intervention and 7, 14, 21 days after begining of the intervention. Method of measurement: questionairre. Shahed University - Faculty of Medical Sciences Approved 2011-05-31 Shahed University Shahed University, Opposite the shrine of Imam Khomeini (RA), Qom Highway beginning, Tehran Thran Iran (Islamic Republic of)