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IRCT20090908002434N8 IRCT 2020-11-15 Shiraz University of Medical Sciences Evaluation of treatment of chronic constipation using combination of Rosa damascene and brown sugar in comparison with polyethylene glycol in children over 12 months old Evaluation of treatment of chronic constipation using combination of Rosa damascene and brown sugar in comparison with polyethylene glycol in children over 12 months old 2020-10-05 anticipated 100 Complete https://irct.ir/trial/48552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible people in the study will be randomly assigned to two groups based on a double-blind study. The random allocation will be blockchain,Four-person blocks that we will have 25 blocks. Twenty-five blocks of four people are selected with random allocation software and people will be assigned to two groups based on these blocks, Blinding description: In this double-blind study, polyethylene glycol syrup in the control group and rose + red sugar syrup based on the evidence of traditional medicine with great effect in the treatment of constipation in the experimental group was used. For this purpose, new patients referred to Imam Reza Clinic of Shiraz University of Medical Sciences After examining and diagnosing constipation, the doctor writes the title of the medicine to treat constipation on the prescription sheet. The patient's initial information is recorded by staff who are also blind, and then the patient is referred to the clinic pharmacy for medication. There, the pharmacy staff, who are blind, give the patient a drug coded by the pharmacist based on a four-item random block table. 3 Constipation. Intervention 1: "intervention group" rosemary extract and red sugar based on the matching of the desired active ingredient in which 1cc / kg / day of rose syrup and rose with 1cc / kg / day of polyethylene glycol 40 syrup % Are equal and in terms of appearance both syrups are the same and are in the same containers are used as a treatment for constipation. After receiving the initial dose, at the end of the second week after treatment, they will be examined by a therapist and Basic information is recorded in the questionnaire. If a clinical response is established, treatment with the same dose will continue for another two weeks, and if no response to treatment is observed, treatment is increased to 2cc / kg / day and patients will be re-examined at the end of the fourth week. The fourth week and the final visit, the patients will be re-evaluated. Patients who received 1cc / kg / day of the drug and the dose was not increased will be re-evaluated for symptom response, and patients who received 2cc / kg / day of anti-constipation therapy for response to treatment Will be evaluated. Intervention 2: Control group: 50 children use polyethylene glycol as a treatment for constipation. Yes - There is a plan to make this available What will be shared: After the research and publication of the article, information about the main outcome and the interventions will be shared. When: At the end of the study since 2021 To whom: All physicians and researchers related to the field of pediatrics Conditions: For therapeutic and research use, information will be provided to all physicians and researchers Where to obtain: Shiraz Namazi Hospital, Pediatric's Department Office, Pediatric Gastroenterology Department How to obtain: By referring to Shiraz Namazi Hospital, Pediatric's Department Office, Pediatric Gastroenterology Department Comments:
public Abbas Avaz Pour
Shiraz university of medical sciences(central building), Zand Street, Shiraz, Fars
Shiraz Iran (Islamic Republic of) 7134874853 +98 71 3647 4298 abbas.avazpour@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Hadi Imanieh
Department of Pediatrics, Namazi Hospital, Namazi Sq
Shiraz Iran (Islamic Republic of) 7134874853 +98 71 1647 4298 imaniehm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Children over 12 months of age with Functional Constipation no underlying disease such as Hirschsprung's disease and metabolic and hypothyroidism 12 months 18 years Both K59.0 constipation Treatment - Drugs Treatment - Drugs "intervention group" rosemary extract and red sugar based on the matching of the desired active ingredient in which 1cc / kg / day of rose syrup and rose with 1cc / kg / day of polyethylene glycol 40 syrup % Are equal and in terms of appearance both syrups are the same and are in the same containers are used as a treatment for constipation. After receiving the initial dose, at the end of the second week after treatment, they will be examined by a therapist and Basic information is recorded in the questionnaire. If a clinical response is established, treatment with the same dose will continue for another two weeks, and if no response to treatment is observed, treatment is increased to 2cc / kg / day and patients will be re-examined at the end of the fourth week. The fourth week and the final visit, the patients will be re-evaluated. Patients who received 1cc / kg / day of the drug and the dose was not increased will be re-evaluated for symptom response, and patients who received 2cc / kg / day of anti-constipation therapy for response to treatment Will be evaluated. Control group: 50 children use polyethylene glycol as a treatment for constipation Defecation less than or equal to two times a week. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Fecal incontinence equal or more than once a week. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. History of stool retention. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. History of hard or painful defecation. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Large fecal mass in the rectum. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. History of thick stools that may block the toilet. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Appetite disorder. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Bad Breath. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Abdominal pain. Timepoint: Start treatment, two weeks later and four weeks later. Method of measurement: Questionnaire. Shiraz University of Medical Sciences Approved 2020-09-20 Ethics Committee of Shiraz University of Medical Sciences Zand Blvd Shiraz Fars Iran (Islamic Republic of)