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IRCT20141209020258N179 IRCT 2023-01-01 Arak University of Medical Sciences Comparison of Pidrolax plus paraffin versus Pidrolaxin the treatment of pediatric functional constipation Comparison of Pidrolax plus paraffin versus Pidrolaxin the treatment of pediatric functional constipation 2023-01-20 anticipated 74 Complete https://irct.ir/trial/66979 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: In this controlled intervention trial, a blinding stage will be performed. In this way, two ready-to-use bottles of medicine labeled A and B will be prepared by the researcher: a bottle containing Pidrolox labeled (A) and a bottle containing liquid paraffin labeled (B). After randomization and grouping by the researcher, with the reference of each Which of the qualified patients will be delivered labeled bottles without the name of the drug (according to the grouping done) and the patient will not be informed of the type of drug treatment. 3 Pediatric functional constipation. Intervention 1: Intervention group 1: will receive 0.7 geram in kilogeram Pidrolaxin in day for 3 months. Intervention 2: Intervention group 2: will receive 0.7 geram in kilogeram in day of Pidrolaxin with liquid paraffin orally for 3 months. 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 more information
public Dr Mojtaba Hashemi
Amirkabir hospital, Parastar squre
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 hashemi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr noshin Sajadi
Amirkabir hospital, Parastar squre
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 sajadi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Outpatients with a history of functional constipation (at least 3 months) 2 to 18 years 2 years 18 years Both Non-functional constipation Resistance to treatment in the first month hypothyroidism hyreshprong disease Known disorders cardiac, renal and neurological Colon surgery history Patients with secondary constipation due to chronic disease such as endocrine, metabolic or neurological diseases K59.9 Functional intestinal disorder, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: will receive 0.7 geram in kilogeram Pidrolaxin in day for 3 months. Intervention group 2: will receive 0.7 geram in kilogeram in day of Pidrolaxin with liquid paraffin orally for 3 months. Frequency of defecation. Timepoint: In week. Method of measurement: Physical examination. Painful defecation. Timepoint: In week. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2022-07-03 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)