]>
IRCT20220104053626N4 IRCT 2022-12-21 Tabriz University of Medical Sciences effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract for colonoscopy preparation comparison of the effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract and polyethylene glycol for colonoscopy preparation. A randomized controlled trial study 2022-12-22 anticipated 116 Complete https://irct.ir/trial/67207 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: From the patients who volunteered to participate in the study, 116 persons will be selected by simple random sampling. Randomization method:block Randomization unit : Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it, Blinding description: This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. Supplements will be provided to patients by another person who has no role in completing the questionnaire and performing colonoscopy. Patients will also be informed of the existence of two types of supplements (polyethylen glycol and Rhamnus frangula extract) when obtaining consent, but will be unaware of which study groups they will be included in. Rhamnus frangula extract sachetes are similar in appearance color, and size to polyethylen glycol sachetes. 2-3 bowel preparation for colonoscopy. Intervention 1: Intervention group: patients will receive 4 sachetes each contain of 500mg Rhamnus frangula extract which will dissolve in a liter of water. they will receive a glass every 6 hours 24 hours before the colonoscopy ,In order to prepare Rhamnus frangula sachet, frangula fruit will be purchased from reputable centers and then dried in a drying machine and ground in a special herb grinder and packed as a powder in the sachetes. Intervention 2: 2nd intervention group: . All patients will receive 4 sachetes of Pidrolax each dissolved in 1litre water and will take a glass every 20 minutes 24 hours before colonoscopy. Pidrolox sachets containing polyethylene glycol 4000 will belong to Sepidaj company. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Masood faghih Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masood Faghih Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) age 18-75 willingness to participate 18 years 75 years Both any history of drug reaction history of disphagia and swallowing dysfunction history of ileus and bowel obstruction and gastroparesia active inflammatory bowel disease electrolyte imbalance renal and liver failure pregnancy and lactation Z12.11 Encounter for screening for malignant neoplasm of colon Treatment - Drugs Treatment - Drugs Intervention group: patients will receive 4 sachetes each contain of 500mg Rhamnus frangula extract which will dissolve in a liter of water. they will receive a glass every 6 hours 24 hours before the colonoscopy ,In order to prepare Rhamnus frangula sachet, frangula fruit will be purchased from reputable centers and then dried in a drying machine and ground in a special herb grinder and packed as a powder in the sachetes. 2nd intervention group: . All patients will receive 4 sachetes of Pidrolax each dissolved in 1litre water and will take a glass every 20 minutes 24 hours before colonoscopy. Pidrolox sachets containing polyethylene glycol 4000 will belong to Sepidaj company. Bowel preparation score. Timepoint: after intervention. Method of measurement: BOSTON score. Tabriz University of Medical Sciences Approved 2021-12-13 Ethics committee of Tabriz University of Medical Sciences Ethic committee, Vice chancellor for research, Faculty of medicine, Tabriz University of Medical Sciences,Golgasht st, Tabriz,Iran Tabriz East Azarbaijan Iran (Islamic Republic of)