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IRCT20190122042459N1 IRCT 2019-02-11 Yazd University of Medical Sciences The effect of whey in the treatment of functional constipation in children The effect of whey in the treatment of functional constipation in children aged 1 to 16 years old 2019-02-20 anticipated 30 Complete https://irct.ir/trial/37061 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple random method using a random number table. N/A Constipation of children. Intervention 1: Intervention group: To a group of patients, Pidrolax powder is given at a dose of 0.8 g / kg , and whey is made by Niak Company for one month (120 cc) per day for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked. Intervention 2: Control group: To a group of patients, Pidrolax powder is given at a dose of 0.8 grams per kilogram of daily weight for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked. 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 No more information
public Fateme Motavasselian
No 1, Etehadie Alley, Shahid Sadoughi Blvd
Yazd Iran (Islamic Republic of) 8951737915 +98 35 3726 3907 motavasselianz@ssu.ac.ir Yazd University of Medical Sciences scientific Majid Emtiazy
Shahid Sadoughi Blvd. Central Office of the University of Medical Sciences
Yazd Iran (Islamic Republic of) 8951737915 +98 35 3223 8915 dr.emtiazy@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age 1 to 16 years chronic functional constipation for at least two months Based on Rome IV Criterion Acquiring parental consent to enter and study it Possibility of patient Follow up 1 year 16 years Both Patients who have been diagnosed with a history of organic constipation Patients with neurological disorder History of Anorectal Surgery Patients who have taken medication more than six months before the study Patients who use a drug other than pidrolax K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: To a group of patients, Pidrolax powder is given at a dose of 0.8 g / kg , and whey is made by Niak Company for one month (120 cc) per day for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked. Control group: To a group of patients, Pidrolax powder is given at a dose of 0.8 grams per kilogram of daily weight for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked. Times of defication. Timepoint: At first, 15 and 30 days after taking the drug. Method of measurement: Parental statements( times in week) Through the questionnaire. Stool consistency. Timepoint: At first, 15 and 30 days after taking the drug. Method of measurement: Bristol stool chart. Yazd University of Medical Sciences Approved 2019-01-05 Ethics Committee of Yazd Shahid Sadoughi University of Medical Sciences Central office of Yazd Shahid Sadoughi University of Medical Sciences,Shahid Sadoughi Blvd Yazd Yazd Iran (Islamic Republic of)