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IRCT20171015036783N2 IRCT 2022-09-05 Shahid Beheshti University of Medical Sciences Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation 2019-07-23 anticipated 100 Complete https://irct.ir/trial/27407 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: The patients will be examined by a gastroenterologist and rejecting the organic causes of constipation. Then will be randomly divided into two groups A and B based on randomly table, Blinding description: This study was performed as a double-blind clinical trial on 100 children aged 1 to 15 years old randomly divided into two groups of 50 patients. After random allocation of patients, the investigator will be assigned to each of the medicines A and B, and the treatment will be followed by the patient or the referring person according to the chosen code. The syrup prepared from both of the two drugs will be quite similar in shape, taste and other factors.Therefore, the doctor and the patients will not be aware of the blindness process. 3 chronic functional constipation. Intervention 1: Intervention group 1: In this group, polyethylene glycol syrup with a concentration of 60 percent with the same dose of 1 milligram per kilogram daily is prescribed in three divided doses after meals. Intervention 2: intervention group 2: In this group, lactose syrup with the same dose of 1 milligram per kilogram daily is administered in three doses after meals. Yes - There is a plan to make this available What will be shared: Comparison of the effect of polyethylene glycol syrup and lactulose syrup in children aged 1 to 15 years with chronic functional constipation referred to gastroenterology clinic of Mofid Hospital When: 6 month after data gathering To whom: All of the researcher aimed at data analyzing. Conditions: For analyzing and using in the researchs. Where to obtain: dr. Naghi Dara How to obtain: Sending request via email or presence. The requesting person's authentication and ensuring the purpose of the research. Sending the data via email or presence within 10 days. Comments:
public Naghi Dara
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2222 7021 drdara49@yahoo.com Shahid Beheshti University of Medical Sciences scientific Naghi Dara
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2222 7021 drdara49@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1-15 years old Chronic Functional Constipation 1 year 15 years Both others causes of constipation K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, polyethylene glycol syrup with a concentration of 60 percent with the same dose of 1 milligram per kilogram daily is prescribed in three divided doses after meals. intervention group 2: In this group, lactose syrup with the same dose of 1 milligram per kilogram daily is administered in three doses after meals. Daily number of deification. Timepoint: weekly in the first month then monthly for 3 months. Method of measurement: bristol stool chart. Daily number of soft defecation. Timepoint: The time periods of measurement to evaluate the number of stools will be visited weekly for one month and then monthly for three months by a gastroenterologist. Method of measurement: A researcher-made checklist will be used to evaluate the number of bowel movements. For this purpose, the checklist will be provided to the parents. Quality of daily defecation. Timepoint: The time periods of measurement to evaluate the quality of stool consistency based on the Bristol chart will be visited weekly for one month and then monthly for three months by a gastroenterologist. Method of measurement: In order to evaluate the quality and consistency of stool, a researcher's checklist based on the Bristol chart will be used. For this purpose, the checklist will be provided to the parents. Shahid Beheshti University of Medical Sciences Approved 2019-03-06 Ethics committee of Shahid beheshti university of medical science 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)